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596 Study Matches

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Use of Multiscale Omics to Develop a Cohort Database and Study Platform in Breast Cancer Survivors

A Study to Develop a Cohort Database and Study Platform in Breast Cancer Survivors Using Multiscale Omics

Brent Bauer
Female
18 years to 75 years old
This study is NOT accepting healthy volunteers
0000-122295-H01-RST
19-005860
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Inclusion Criteria:

  • Adult females enrolled in the Mayo Clinic Biospecimen Resource for Breast Disease (IRB # 1815-04).
  • Current ages 18-75 years.
  • Have a prior diagnosis of stage 0-3 (in situ or invasive) breast cancer (BCS).
  • Have completed active therapy (surgery, radiation, and/or chemotherapy) (8-30  months approximately) prior to provision of the samples).
  • Age-matched females with no history of cancer (other than non-melanoma skin cancer) may be selected from the PRISM Study (IRB #18-002366 The Predicting Risk after Screening Mammogram (PRISM) Study) or the Mayo Clinic Breast Mammography practice.


Exclusion Criteria:
 

  • Male biological sex or gender.
  • Pregnant females (insufficient #s, skewed estrogen levels).
  • Unwilling to travel to Mayo Clinic Rochester to provide the blood and urine samples.
Breast cancer, Cancer, Ductal carcinoma in situ, Invasive lobular carcinoma, Lobular carcinoma in situ
Breast cancer supportive therapy and survivorship service, Chemotherapy, Chemotherapy for breast cancer, History of antineoplastic chemotherapy, History of carcinoma in situ of breast, History of invasive malignant neoplasm of breast, History of mastectomy, History of radiation therapy to breast area, Malignant tumor of breast, Mammogram, Medical Oncology
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Mayo Clinic — Rochester, MN

Premier Hb9210TM Resolution System Reference Range Study Protocol

A Study of the Premier Hb9210TM Resolution System

James Hoyer
All
12 years to 22 years old
This study is NOT accepting healthy volunteers
0000-122330-P01-RST
19-006149
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Inclusion Criteria:

  • Ages 18 to 22 years old.


Exclusion Criteria:

  • Subjects outside the inclusion criteria age range.
Hemoglobin test
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Mayo Clinic — Rochester, MN

Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Ocular Hypertensive Subjects

A Study to Evaluate the Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Participants With Ocular Hypertension

Arthur Sit
All
18 years and over
Phase 4
This study is NOT accepting healthy volunteers
0000-122641-P01-RST
19-009222
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General

Inclusion Criteria:

  • Subjects must be ≥18 years of age, must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)‑approved ICF and are able and willing to comply with all treatment and follow-up/study procedures.
  • Females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must agree to use an acceptable method of contraception throughout their participation in the study.

Ocular

Inclusion Criteria:

  • Subjects must have a diagnosis of OHT in both eyes (IOP ≥ 22 mmHg prior to starting treatment with IOP-lowering medication) without evidence of glaucomatous optic neuropathy or visual field loss and have been receiving IOP-lowering medication for ≥ 3 months prior to Visit 1.
  • Subjects must undergo a washout of any existing ocular hypotensive medications in order to determine eligibility. Washout period will vary with the class of medication used (2-6 weeks).
  • Subjects must meet the following IOP requirements at Visit 3 (Eligibility Visit at End of Washout):
    • Intraocular pressure ≥ 22 mmHg and ≤ 32 mmHg in both eyes;
    • An increase in IOP of ≥ 20% over the screening visit (Visit 1) IOP in both eyes;
    • A difference in IOP between eyes ≤ 4 mmHg.
  • Subjects must have a BCVA in each eye of 20/50 (LogMAR +0.4) or better.

General


Exclusion Criteria:

  • Subjects participating in any drug or device clinical investigation within 30 days prior to Visit 1 (Screening) or who anticipate participating in any other drug or device clinical investigation within the duration of this study. 
  • Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study.
  • Female subjects who are pregnant or breastfeeding.
  • Subjects with Body Mass Index (BMI) ≥ 40.0. Subjects with BMI 35.0-39.9 may be excluded at the discretion of the PI.

Ocular


Exclusion Criteria:

Diseases

  • Participants who are unable to discontinue contact lens use during and for 15 minutes following instillation of study drug and for 24 hours before check-in and during each study visit.
  • Participants with a central corneal thickness less than 480 μm or greater than 600 micrometer (μm) in either eye.
  • Participants with any condition that prevents reliable applanation tonometry (for example, significant corneal surface abnormalities) in either eye. 
  • Participants who are monocular. 
  • Participants with ocular conditions, which, in the opinion of the Investigator, will impact the study measurements, such as:
    • Active optic disc hemorrhage in either eye;
    • Current or a history of central/branch retinal vein or artery occlusion in either eye;
    • Current or a history of macular edema in either eye;
    • Very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and participants with angle closure, congenital, and secondary glaucoma, and with history of angle closure in either eye;
    • Diagnosis of a clinically significant or progressive retinal disease (for example, diabetic retinopathy, exudative or severe non-exudative macular degeneration) in either eye.
  • Participants with any intraocular infection or inflammation in either eye within 3 months prior to Visit 1 (Screening). 
  • Myopia greater than -4.00 diopter (D), or hyperopia greater than +2.000 Surgery.
  • Participants with a history of ocular laser surgery in either eye within the 3 months (90 days) prior to Visit 1 (Screening).
  • Participants with a history of laser trabeculoplasty, cyclophotocoagulation or glaucoma surgical procedures at any time prior to Visit 1 (Screening). 
  • Participants with a history of incisional ocular surgery other than routine uncomplicated cataract surgery or severe trauma in either eye within the 3 months (90 days) prior to Visit 1 (Screening).

Eligibility last updated 2/28/22. Questions regarding updates should be directed to the study team contact.

Drug, Other, Administration of drug or medicament via ophthalmic route, Drug therapy, Measurement of episcleral venous pressure using venomanometer, Provocative outflow facility test
Glaucoma, High blood pressure
Latanoprostene BUNOD [USAN:INN], Ocular hypertension, latanoprostene bunod, Cardiovascular system
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Mayo Clinic — Rochester, MN

A Prospective, Observational, Multicenter, Open-Label, Pilot Study to Investigate Medication Adherence and Patient Reported Symptom Occurrence and Interference with Daily Life Comparing Once-Daily Envarsus XR® and Twice-Daily Immediate Release Tacrolimus in Adult Renal Transplant Recipients (SIMPLE)

A Study to Evaluate the Safety and Effectiveness of Once-Daily Envarsus XR? and Twice-Daily, Immediate-Release Tacrolimus in Adult Renal Transplant Recipients

Mark Stegall
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121943-H01-RST
19-002678
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Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  • Patient is an adult (18 years of age or older).
  • Treatment with Envarsus XR® or immediate-release, twice-daily tacrolimus has been indicated by patient’s transplant care team. 
  • Patient is a recipient of a deceased or living donor kidney transplant.
  • Patient is able to comply with study procedures for the entire length of the study.
  • Patient has been informed about the study survey and has signed an informed consent form.


Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Patient is unable or unwilling to complete study patient reported outcome questionnaires.
  • Patient is currently receiving azathioprine
  • Patient is currently receiving an mTOR inhibitor (sirolimus, everolimus)
  • Patient is currently receiving belatacept .
  • Patient has received investigational immunosuppression 1 month prior to transplant or post-transplant.
  • Patient is in a setting where a professional care taker is responsible for dispensing subject’s medication.
Deceased donor kidney transplant, Kidney transplant, Living donor kidney transplant, Nephropathy induced by tacrolimus, Tacrolimus, Transplanted kidney present, tacrolimus
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Mayo Clinic — Rochester, MN

Reiki Therapy – An Intervention in Hematology/Oncology Cancer Patients Hospitalized in an Inpatient Setting – A Pilot Study

A Study to Evaluate Reiki Therapy as an Intervention in Hematology/Oncology Cancer Patients Hospitalized in an Inpatient Setting

Brent Bauer
All
18 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-121699-H01-RST
19-000456
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Inclusion Criteria:

  • Hospitalized hematology-oncology patients, age 18 – 80 years old.
  • Able to speak English and complete surveys.
  • Able to read, understand and sign inform consent.

 


Exclusion Criteria:
 

  • Patient unwilling for reiki therapy.
  • Unable to give written consent.
  • Already having received or receiving other reiki treatment.
  • Pregnant women. (as verbalized by participant)/

 

Other, Reiki
Cancer
Cancer treatment, Integrative medicine, Malignant neoplastic disease, Medical Oncology
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Mayo Clinic — Rochester, MN

A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (≥ 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

A Study to Evaluate Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Older Patients With Untreated Chronic Lymphocytic Leukemia

Amrit Singh
All
65 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100026-P01-MAIJ
19-000587
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Inclusion Criteria:
 

PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)

  • Patients must have been diagnosed with CLL and have > 5000 B-cells per uL of peripheral blood at any point during the course of their disease.
  • This blood submission is mandatory prior to registration/randomization to perform FISH centrally that will be used for stratification. It should be obtained as soon after preregistration as possible.

REGISTRATION ELIGIBILITY CRITERIA (STEP 1) 

  • Patients must be diagnosed with CLL in accordance with 2018 IWCLL criteria [28] that includes all of the following:
    • ≥ 5 x10^9 B lymphocytes (5000/μL) in the peripheral blood measured by flow cytometry at any point in the course of the disease;
    • On local morphologic review, the leukemic cells must be small mature lymphocytes, and prolymphocytes must not exceed 55% of the blood lymphocytes;
    • CLL cells on immunophenotype (performed locally) must reveal a clonal B-cell population, which express the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5. Patients with bright surface immunoglobulin expression or lack of CD23 expression in >10% of cells must lack t(11;14) translocation by interphase cytogenetics.
  • Patients must be intermediate or high-risk Rai stage CLL.
    • Intermediate risk (formerly Rai stage I/II) is defined by lymphocytosis plus any of the following: enlarged lymph nodes, hepatomegaly, or splenomegaly'
    • High risk (formerly Rai stage III/IV) is defined by lymphocytosis with or without enlarged nodes and spleen plus disease-related anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelet count < 100 x 10^9/L) that is not attributable to autoimmune hemolytic anemia or thrombocytopenia.
  • Patients must meet criteria for treatment as defined by 2018 IWCLL guidelines which includes at least one of the following criteria:
    • Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia);
    • Massive (≥ 6 cm below the costal margin), progressive or symptomatic splenomegaly;
    • Massive nodes (≥ 10 cm) or progressive or symptomatic lymphadenopathy;
    • Progressive lymphocytosis with a lymphocyte doubling time < 6 months or an increase of ≥ 50% over a 2 month period;
    • Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy;
    • Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine);
    • Constitutional symptoms, which include any of the following:
      • Unintentional weight loss of 10% or more within 6 months;
      • Significant fatigue;
      • Fevers >100.5 degrees F for 2 weeks or more without evidence of infection;
      • Night sweats ≥1 month without evidence of infection.
  • Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids).
  • Treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration.
  • Age ≥ 65 years.
  • ECOG performance status 0-2.
  • Required initial laboratory values.
  • Absolute Neutrophil Count (ANC) ≥ 1,000/mm^3 except if due to bone marrow involvement.
  • Platelet Count (untransfused) ≥ 30,000/mm^3.
  • Calc. Creatinine Clearance ≥ 40 mL/min (by Cockcroft-Gault).
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN) except if due to liver involvement, hemolysis, or Gilbert’s disease.
  • AST / ALT ≤ 2.5 x upper limit of normal (ULN) except if due to liver involvement.
  • Patients must not have any history of Richter’s transformation or prolymphocytic leukemia (prolymphocytes in blood > 55%).
  • If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated.
    • Please note: IVIG can cause a false positive hepatitis B serology. If patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician.
  • If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load.
  • Patients with Class III or Class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible.
  • Patients who have had a myocardial infarction, intracranial bleed, or stroke within the past 6 months are not eligible.
  • Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Patients must not be receiving active systemic anticoagulation with heparin or warfarin. Patients on warfarin must discontinue the drug for at least 10 days prior to registration on the study.
  • Chronic concomitant treatment with strong inhibitors of CYP3A4/5 is not allowed on this study. Patients on strong CYP3A inhibitors must discontinue the drug for 14 days prior to registration on the study. 
  • Chronic concomitant treatment with strong CYP3A4/5 inducers is not allowed.
  • Patients must discontinue the drug 14 days prior to registration on the study.
  • Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily.
  • Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics.
  • Central FISH blood results are mandatory prior to registration/randomization for it will be used for stratification.
  • Patients must be able to swallow capsules and not have the following conditions:  disease significantly affecting gastrointestinal absorption, resection of the stomach or small bowel, partial or complete bowel obstruction.
  • Patients must not have a known allergy to mannitol.
  • Patients must not have prior significant hypersensitivity to rituximab (not including infusion reactions).
  • Patients may not have had major surgery within 10 days prior to registration, or minor surgery within 7 days prior to registration. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration for a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician.
  • Patients must be able to receive either a xanthine oxidase inhibitor or rasburicase for prophylaxis/treatment of TLS.

RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2)

  • Completion of treatment through Cycle 14 Day 28, and remain on ibrutinib therapy.
  • Receipt of central BM MRD results.
  • Response assessment completed per Section 5.0 with CR determination.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

 

Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Cancer, Chronic lymphocytic leukemia, Leukemia
4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide, Afutuzumab, Biological therapy for cancer, Cancer treatment, Chemotherapy, Chronic lymphoid leukemia, disease, Hematopoietic system, Ibrutinib [USAN:INN], Medical Oncology, Targeted drug therapy, ibrutinib, obinutuzumab, venetoclax
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Mayo Clinic Health System — Mankato, MN

A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (≥ 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

A Study to Evaluate Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Older Patients With Untreated Chronic Lymphocytic Leukemia

Wei Ding
All
65 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100026-P01-RST
19-000587
Show full eligibility criteria
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Inclusion Criteria:
 

PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)

  • Patients must have been diagnosed with CLL and have > 5000 B-cells per uL of peripheral blood at any point during the course of their disease.
  • This blood submission is mandatory prior to registration/randomization to perform FISH centrally that will be used for stratification. It should be obtained as soon after preregistration as possible.

REGISTRATION ELIGIBILITY CRITERIA (STEP 1) 

  • Patients must be diagnosed with CLL in accordance with 2018 IWCLL criteria [28] that includes all of the following:
    • ≥ 5 x10^9 B lymphocytes (5000/μL) in the peripheral blood measured by flow cytometry at any point in the course of the disease;
    • On local morphologic review, the leukemic cells must be small mature lymphocytes, and prolymphocytes must not exceed 55% of the blood lymphocytes;
    • CLL cells on immunophenotype (performed locally) must reveal a clonal B-cell population, which express the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5. Patients with bright surface immunoglobulin expression or lack of CD23 expression in >10% of cells must lack t(11;14) translocation by interphase cytogenetics.
  • Patients must be intermediate or high-risk Rai stage CLL.
    • Intermediate risk (formerly Rai stage I/II) is defined by lymphocytosis plus any of the following: enlarged lymph nodes, hepatomegaly, or splenomegaly'
    • High risk (formerly Rai stage III/IV) is defined by lymphocytosis with or without enlarged nodes and spleen plus disease-related anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelet count < 100 x 10^9/L) that is not attributable to autoimmune hemolytic anemia or thrombocytopenia.
  • Patients must meet criteria for treatment as defined by 2018 IWCLL guidelines which includes at least one of the following criteria:
    • Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia);
    • Massive (≥ 6 cm below the costal margin), progressive or symptomatic splenomegaly;
    • Massive nodes (≥ 10 cm) or progressive or symptomatic lymphadenopathy;
    • Progressive lymphocytosis with a lymphocyte doubling time < 6 months or an increase of ≥ 50% over a 2 month period;
    • Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy;
    • Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine);
    • Constitutional symptoms, which include any of the following:
      • Unintentional weight loss of 10% or more within 6 months;
      • Significant fatigue;
      • Fevers >100.5 degrees F for 2 weeks or more without evidence of infection;
      • Night sweats ≥1 month without evidence of infection.
  • Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids).
  • Treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration.
  • Age ≥ 65 years.
  • ECOG performance status 0-2.
  • Required initial laboratory values.
  • Absolute Neutrophil Count (ANC) ≥ 1,000/mm^3 except if due to bone marrow involvement.
  • Platelet Count (untransfused) ≥ 30,000/mm^3.
  • Calc. Creatinine Clearance ≥ 40 mL/min (by Cockcroft-Gault).
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN) except if due to liver involvement, hemolysis, or Gilbert’s disease.
  • AST / ALT ≤ 2.5 x upper limit of normal (ULN) except if due to liver involvement.
  • Patients must not have any history of Richter’s transformation or prolymphocytic leukemia (prolymphocytes in blood > 55%).
  • If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated.
    • Please note: IVIG can cause a false positive hepatitis B serology. If patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician.
  • If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load.
  • Patients with Class III or Class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible.
  • Patients who have had a myocardial infarction, intracranial bleed, or stroke within the past 6 months are not eligible.
  • Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Patients must not be receiving active systemic anticoagulation with heparin or warfarin. Patients on warfarin must discontinue the drug for at least 10 days prior to registration on the study.
  • Chronic concomitant treatment with strong inhibitors of CYP3A4/5 is not allowed on this study. Patients on strong CYP3A inhibitors must discontinue the drug for 14 days prior to registration on the study. 
  • Chronic concomitant treatment with strong CYP3A4/5 inducers is not allowed.
  • Patients must discontinue the drug 14 days prior to registration on the study.
  • Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily.
  • Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics.
  • Central FISH blood results are mandatory prior to registration/randomization for it will be used for stratification.
  • Patients must be able to swallow capsules and not have the following conditions:  disease significantly affecting gastrointestinal absorption, resection of the stomach or small bowel, partial or complete bowel obstruction.
  • Patients must not have a known allergy to mannitol.
  • Patients must not have prior significant hypersensitivity to rituximab (not including infusion reactions).
  • Patients may not have had major surgery within 10 days prior to registration, or minor surgery within 7 days prior to registration. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration for a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician.
  • Patients must be able to receive either a xanthine oxidase inhibitor or rasburicase for prophylaxis/treatment of TLS.

RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2)

  • Completion of treatment through Cycle 14 Day 28, and remain on ibrutinib therapy.
  • Receipt of central BM MRD results.
  • Response assessment completed per Section 5.0 with CR determination.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

 

Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Cancer, Chronic lymphocytic leukemia, Leukemia
4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide, Afutuzumab, Biological therapy for cancer, Cancer treatment, Chemotherapy, Chronic lymphoid leukemia, disease, Hematopoietic system, Ibrutinib [USAN:INN], Medical Oncology, Targeted drug therapy, ibrutinib, obinutuzumab, venetoclax
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Mayo Clinic — Rochester, MN

Genomically-Guided Treatment Trial in Brain Metastases

A Study to Evaluate Genetic Testing in Guiding Treatment for Patients with Brain Metastases

Sani Kizilbash
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100069-P01-RST
19-010598
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Inclusion Criteria:

PRE-REGISTRATION ELIGIBILITY CRITERIA (ALL PATIENTS)

  • Tissue available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy).

REGISTRATION ELIGIBILITY CRITERIA (ALL PATIENTS)

  • Participants must have histologically confirmed metastatic disease to the brain from any solid tumor. Note: this includes patients that have controlled extracranial disease with progressive intracranial metastasis, as well as patients that have progressive intracranial and extracranial disease. 
  • New or progressive brain metastases are defined as any one of the following: 
    • Untreated measurable lesions in patients who have received surgery and/or stereotactic radiosurgery (SRS) to one or more other lesions; 
    • Residual or progressive lesions after surgery if asymptomatic; 
    • Patients who have had prior whole-brain radiotherapy (WBRT) and/or SRS and then whose lesions have progressed by BM-RANO criteria or there are new lesions, are eligible. Lesions treated with SRS may be eligible if there is unequivocal evidence of progression;
    • Patients who have not previously been treated with cranial radiation (e.g., WBRT or SRS) are eligible, but such patients must be asymptomatic or neurologically stable from their CNS metastases. 
  • Measurable CNS disease (> 10 mm). 
  • Ability to obtain magnetic resonance imaging (MRI)s. 
  • No surgery within 2 weeks prior to or after registration.
  • No chemotherapy within 14 days prior to registration
    • Note: for abemaciclib arm, a 21-day chemotherapy washout is required).
    • For melanoma, patients must have progressed after prior immune checkpoint blockade or for BRAF positive melanoma, BRAF/MEK inhibitors.
    • For lung cancer, EGFR mutant patients must have failed EGFR therapies
    • For HER2-positive breast cancer patients, patients must have received at least one prior HER-2 directed therapy in the metastatic setting.
    • For triple negative breast cancer (TNBC), patients must have received at least one chemotherapy in the metastatic setting. 
    • For estrogen receptor (ER)/progesterone receptor (PR)+ breast cancer, patients must have received at least one endocrine therapy in the metastatic setting. 
    • Breast cancer patients who have received ribociclib or palbociclib are eligible as long as there is documentation of CDK4 pathway alteration on a biopsy at the point of progression post-ribociclib or palbociclib.
  • Tissue available for sequencing (any brain metastasis tissue and extracranial site from any prior resection or biopsy that was resected as part of clinical care). If the patient does not have any evidence of extracranial disease, brain metastasis tissue is sufficient for eligibility.
  • Presence of clinically actionable alteration in NTRK, ROS1, or CDK pathway or PI3K pathway in both a brain metastasis and extracranial site. 
  • Not pregnant and not nursing, because this study involves investigational agents whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required.
    • Note: for abemaciclib arm, pregnancy test is required ≤ 7 days prior to registration.
    • No known leptomeningeal involvement. 
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Adequate organ function.
    •Absolute neutrophil count (ANC) ≥ 1,500/mm^3.
  • Platelet count ≥ 100,000/mm^3. 
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except in patients with Gilbert's disease. 
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN). 
  • Creatinine ≤ 1.5 mg/dL OR calculated (Calc.) creatinine clearance > 45 mL/min. 
  • No uncontrolled medical comorbidities per investigator discretion (e.g., interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
  • Concurrent radiation to symptomatic non-target sites within neural axis is allowed (provided there is at least one untreated target lesion). 
  • Concurrent systemic corticosteroids are allowed if stable dose of dexamethasone for 7 days prior to registration. Baseline doses and changes in steroid dosing will be captured. 
  • No concurrent administration of anticancer therapies (except for endocrine therapy or continuation of hormonal therapy or trastuzumab in breast cancer patients). No chemotherapy, targeted therapy or immunotherapy within 14 days prior to entering the study
    •  Note: For abemaciclib arm, a 21-day chemotherapy washout is required. 
  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug 14 days prior to registration on the study. 
  • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.

ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR GDC-0084 ARM

  • Urine protein to creatinine (UPC) ratio < 1 or urine protein ≤ 1. 
  • Recent acute myocardial infarction in the last 6 months or current angina pectoris are excluded. Patients with symptomatic bradycardia should have an electrocardiogram at baseline. If QT interval > 470 msec, the patient is excluded. 
  • Patients with uncontrolled type I or II diabetes mellitus should be excluded. Uncontrolled diabetes is defined as glycosylated hemoglobin (HbA1c) > 9% in addition to fasting glucose > 140 mg/dL on at least 2 occasions within 14 days prior to registration.

ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ENTRECTINIB ARM

  • Concurrent use of H2 receptor antagonists, receptor antagonists, proton pump inhibitors (PPIs), and/or antacids are prohibited.

ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM

  • Hemoglobin ≥ g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion. 
  • Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and registration (provided the patient did not receive radiotherapy). 
  • Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and registration. 
  • For females of childbearing potential: A female of childbearing potential, must have a negative serum pregnancy test within 7 days prior to registration and agree to use a highly effective contraception method during the treatment period and for 3 weeks following the last dose of abemaciclib. Contraceptive methods may include an intrauterine device [IUD] or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. Cases of pregnancy that occur during maternal exposures to abemaciclib should be reported. If a patient or spouse/partner is determined to be pregnant following abemaciclib initiation, she must discontinue treatment immediately. Data on fetal outcome and breast-feeding are to be collected for regulatory reporting and drug safety evaluation. 
  • Patients with active bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive] are excluded. Screening is not required for enrollment.
  • Patients with personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest, are excluded.
Drug, Genetic
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A031702, A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

A Study to Test the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) with One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

Lance Pagliaro
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100201-P01-RST
19-005143
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Eligibility Criteria: 

  • Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan. Patients must have at least:
    • One measurable site of disease as per RECIST v1.1;
    • One bone lesion on bone scan (tec99 or NaF PET/CT, CT or MRI) for the bone-only cohort;
  • Histologically confirmed diagnosis of one of the following metastatic cohorts:
  • Small cell/ neuroendocrine carcinoma of the bladder - All urothelial carcinomas with any amount of neuroendocrine differentiation (including small cell differentiation) will be included. If the tumor is purely neuroendocrine, metastasis from another site of origin should be clinically excluded;
  • Adenocarcinoma of the bladder, or urachal adenocarcinoma, or bladder/urethra clear cell adenocarcinoma - must be pure (per WHO definition), (i.e. urothelial carcinoma with glandular differentiation is not considered a pure adenocarcinoma;
  • Squamous cell carcinoma of the bladder
    must be pure (i.e. urothelial carcinoma with squamous differentiation is not considered a pure squamous cell carcinoma);
  • Plasmacytoid urothelial carcinoma - Tumor should show predominantly > or equal ~50% plasmacytoid histology (including all types of discohesive growth, such as tumors with signet-ring and/or rhabdoid features as well).
  • Any penile cancer;
  • Sarcomatoid renal cell carcinoma - Tumor should be predominantly sarcomatoid ~50% (including rhabdoid differentiation) is also unclassified RCCs: all (assuming they are high grade with metastasis) malignant angiomyolipomas are allowed;
  • Sarcomatoid urothelial carcinoma - Tumor should show predominantly ~ 50% sarcomatoid differentiation;
  • Renal medullary carcinoma - Per WHO definition, ideally confirmed with immunostains;
  • Renal Collecting Duct Carcinoma
    Per WHO definition (medullary involvement, predominant tubular morphology, desmoplastic stromal reaction, high grade cytology, infiltrative growth pattern, and absence of other renal cell carcinoma subtype or urothelial carcinoma);
  • Bone only urothelial carcinoma or other non-prostate GU tumor;
  • Urethra carcinoma- May be of any histology but if urothelial carcinoma then must be isolated to the urethra and not have metachronous or synchronous urothelial carcinoma of the bladder;
  • Other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to: micropapillary (Tumor should show predominantly > or equal 50% micropapillary architecture), giant cell, lipid-rich, clear cell and nested variants (Tumor should predominantly > or equal 50% show these features), large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer (Only treatment-naïve primary small cell of prostate with any amount of small cell component allowed. Post-treatment small cell prostatic carcinomas are not allowed), Malignant testicular Sertoli or Leydig cell tumors, and papillary and chromophobe RCC.Note: Translocation positive renal cell carcinoma patients are eligible. However, AREN1721 should be considered before this trial.
  • H&E slides from diagnostic tumor tissue for retrospective central pathology review.
  • Patients may have received up to 2 systemic anti-cancer treatments or be treatment naïve. Patients with small cell carcinoma should have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment). Patients in the bone-only cohort may be urothelial carcinoma histology but must receive standard cisplatin-based chemotherapy (if cisplatin- eligible).
  • Age ≥ 18 years.
  • Patients must be able to swallow oral formulation of the tablets.
  • Karnofsky performance status ≥ 80%.
  • Required Laboratory Values:
    • Absolute Neutrophil Count (ANC) ≥1,000/mcL;
    • Platelet Count ≥ 75,000/mcL;
    • Total Bilirubin ≤1.5 × ULN. For subjects with known Gilbert’s disease or similar syndrome with slow conjugation of bilirubin, total bilirubin ≤ 3.0 mg/dL AST/ALT ≤3.0 × institutional upper limit of normal (ULN) (or ≤5 x ULN for patients with liver metastases or Gilbert’s disease);
    • Creatinine ≤ 1.5 x upper limit of normal (ULN); OR
    • Creatinine clearance ≥ 40 mL/min/1.73 m2 (calculated using the CKD-EPI equation or Cockroft-Gault formula) for patients with creatinine levels above institutional normal hemoglobin ≥9 g/dL (transfusion of PRBCs allowed) serum albumin ≥3.2g/dL lipase and amylase ≤2.0 × ULN and no radiologic (on baseline anatomical imaging) or clinical evidence of pancreatitis.
  • Prior treatment with MET or VEGFR inhibitors is allowed. However, prior cabozantinib will not be allowed. Also, patients that have received both prior MET or VEGF and prior PD-1/PD-L1/CTLA-4 (sequentially or in combination) are also not allowed.
  • Prior treatment with any therapy on the PD-1/PD-L1 axis or anti- CTLA- 4/CTLA-4 inhibitors is allowed, either in the perioperative or in the metastatic setting. However, patients that have received both prior MET or VEGF and prior PD-1/PD- L1/CTLA-4 (sequentially or in combination) are not allowed.
  • HIV-positive patients are eligible if on stable dose of highly active antiretroviral therapy (HAART) and no clinically significant drug-drug interactions are anticipated with the current HAART regimen, CD4 counts are greater than 350 and viral load is undetectable.
  • Patients with rheumatoid arthritis and other rheumatologic arthropathies, Sjögren’s syndrome and psoriasis controlled with topical medication only and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies etc. are eligible but should be considered for rheumatologic evaluation for the presence of target organ involvement and potential need for systemic treatment.
  • Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones or medications (eg thyrodidits managed with PTU or methamizole) including physiologic oral corticosteroids are eligible.
  • Patients who have evidence of active or acute diverticulitis, intra-abdominal abscess, and GI obstruction, within 12 months are not eligible.
  • Women of childbearing potential must have a negative pregnancy test ≤ 7 days prior to registration.
  • Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Post menopause is defined as amenorrhea ≥12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason.
  • Pregnant women may not participate in this study because with cabozantinib, nivolumab, and ipilimumab have potential for teratogenic or abortifacient effects.
  • Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cabozantinib, nivolumab, and ipilimumab, breastfeeding should be discontinued if the mother is treated with these agents.
  • The patient has received no cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 2 weeks before the first dose of study treatment.
  • The patient has received no radiation therapy:
    • To the lungs and mediastinum or abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy;
    • To brain metastasis within 3 weeks for WBXRT, and 2 weeks for SBRT before the first dose of study treatment;
    • To the abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy;
    • To any other site(s) within 2 weeks before the first dose of study treatment.
  • The patient has received no radionuclide treatment within 6 weeks of the first dose of study treatment.
  • The patient has received no prior treatment with a small molecule kinase inhibitor within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment.
  • The patient has received no prior treatment with hormonal therapy within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment. Subjects receiving Gonadotropin-releasing hormone (GnRH) agonists and antagonists are allowed to participate.
  • The patient has not received any other type of investigational agent within 14 days before the first dose of study treatment.
  • The patient must have recovered to baseline or CTCAE ≤ Grade 1 from toxicity due to all prior therapies except alopecia, neuropathy and other non-clinically significant AEs defined as lab elevation with no associated symptoms or sequelae.
  • The patient may not have active brain metastases or epidural disease. Patients with brain metastases previously treated with whole brain radiation or radiosurgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible. Neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment. Baseline brain imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility.
  • No concomitant treatment with warfarin. Aspirin (up to 325 mg/day), thrombin or factor Xa inhibitors, low-dose warfarin (≤1 mg/day), prophylactic and therapeutic low molecular weight heparin (LMWH) are permitted.
  • No chronic concomitant treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John’s Wort) or strong CYP3A4 inhibitors.
  • Because the lists of these agents are constantly changing, it is important to regularly consult medical reference texts such as the Physicians’ Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
  • The patient has not experienced any of the following:
    • Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment;
    • Hemoptysis of ≥ 0.5 teaspoon (2.5 mL) of red blood per day within 1 months before the first dose of study treatment;
    • Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment.
  • The patient has no tumor invading any major blood vessels.
  • The patient has no evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib. Patients with rectal tumor masses are not eligible.
  • The patient has no uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions.  Cardiovascular disorders including:
    • Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening;
    • Concurrent uncontrolled hypertension defined as sustained BP > 150 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment;
    • The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) >500 ms within 28 days before randomization.
    • Note: if initial QTcF is found to be > 500 ms, two additional EKGs separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is ≤500 ms, the subject meets eligibility in this regard.
    • Any history of congenital long QT syndrome.
  • Any of the following within 6 months before registration of study treatment:
    • unstable angina pectoris;
    • clinically-significant cardiac arrhythmias (patients with atrial fibrillation are eligible);
    • stroke (including TIA, or other ischemic event)
    • myocardial infarction
    • cardiomyopathy.
  • No significant gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:
    • Any of the following that have not resolved within 28 days before the first dose of study treatment:
    • Acute diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or malabsorption syndrome;
    • Active peptic ulcer disease;
    • None of the following within 2 years before the first dose of study treatment:
    • abdominal fistula or genitourinary fistula
    • gastrointestinal perforation
    • bowel obstruction or gastric outlet obstruction
    • intra-abdominal abscess.
      • Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 2 years before the first dose of study treatment.
  • Disorders associated with a high risk of fistula formation including PEG tube placement are not eligible.
  • No other clinically significant disorders such as:
    • severe active infection requiring IV systemic treatment within 14 days before the first dose of study treatment
    • serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment
    • history of organ or allogeneic stem cell transplant
    • concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment (for asymptomatic patients with an elevated TSH, thyroid replacement may be initiated if clinically indicated without delaying the start of study treatment)
    • No history of major surgery as follows:
    • Major surgery within 3 months of the first dose of cabozantinib; however, if there were no wound healing complications, patients with rapidly growing aggressive cancers, may start as soon as 6 weeks if wound has completely healed post- surgery.
    • Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications excluding core biopsies and mediport placement.
  • Complete wound healing from prior surgery must be confirmed before the first dose of cabozantinib irrespective of the time from surgery.
  • No history of severe hypersensitivity reaction to any monoclonal antibody.
  • No evidence of active malignancy, requiring systemic treatment within 2 years of registration.
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib, nivolumab, ipilimumab or other agents used in study.
  • No positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. If HBV sAG is positive, subsequent RNA PCR must be negative.
  • No patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include, but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease.

Please Note: While patients may meet eligibility criteria, treating physicians should use best judgement to assess if the patient is a good candidate for this therapy with three drug combination regimen.

 

 

 

Biologic/Vaccine, Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Bladder cancer, Cancer, Germ cell tumor, Kidney cancer, Neuroendocrine carcinoma, Prostate cancer, Testicular cancer, Neuroendocrine tumor
Adenocarcinoma of bladder, Biological therapy for cancer, Cabozantinib, Cancer treatment, Chemotherapy, Chromophobe renal cell carcinoma, Ipilimumab, Large cell neuroendocrine carcinoma, Leydig cell neoplasm of testis, Lymphoepithelial carcinoma, MDX-1106, Malignant tumor of penis, Malignant tumor of prostate, Malignant tumor of urinary bladder, Medical Oncology, Metastatic penile cancer, Metastatic renal cell carcinoma, Papillary renal cell carcinoma, Renal cell carcinoma, Renal cell carcinoma, sarcomatoid, Renal medullary carcinoma, Reproductive system, Secondary malignant neoplastic disease, Sertoli cell tumor of testis, Small cell neuroendocrine carcinoma of bladder, Squamous cell carcinoma of bladder, Targeted drug therapy, Transitional cell carcinoma, micropapillary, Transitional cell carcinoma, spindle cell, Urinary system, cabozantinib, ipilimumab, nivolumab
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EA1151, Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

A Study of 3-D Digital Mammography to Screen Patients for Breast Cancer

Katie Hunt
Female
45 years to 74 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-100404-P01-RST
19-004054
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Inclusion Criteria:
 

  • Patients must be women age 45 or older and under age 75 at the time of study entry.
  • Women of childbearing potential must not be known to be pregnant or lactating.
  • Patients must be scheduled for, or have intent to schedule, a screening mammogram.
  • Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol, to be performed at an American College of Radiology Imaging Network (ACRIN)-qualified facility.
  • Patients must be willing and able to provide a written informed consent.
  • Patients must not have new symptoms or signs of benign or malignant breast disease (e.g., bloody or clear nipple discharge, breast lump) based on physician physical exam or self breast exam that have not been previously worked up with imaging. Patients with physiologic nipple discharge or breast pain are eligible as long as other criteria are met.
  • Patients must not have had a screening mammogram within the last 11 months prior to date of randomization.
  • Patients must not have previous personal history of breast cancer including ductal carcinoma in situ.
  • Patients must not have breast enhancements (e.g., implants or radiopaque injections).

ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK 

To be eligible for inclusion in the annual screening regimen one of the following three conditions must be met in addition to the eligibility criteria above:

  • Patients are pre-menopausal; or
  • Post-menopausal aged 45-69 with any of the following four risks factors:
    • Dense Breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
    • At least one benign breast biopsy with a diagnosis of Lobular Carcinoma in Situ (LCIS) or atypia of any kind (atypical ductal hyperplasia, atypical lobular hyperplasia, atypical hyperplasia NOS, or intraductal papilloma with atypia), or
    • Family history of breast cancer (first degree relative with breast cancer) or family history of breast cancer is not known, or, participant positive genetic testing for any deleterious genes that indicate an increased risk for breast cancer, or
    • Currently on hormone therapy¹; or
  • Post-menopausal ages 70-74 with either of the following three risk factors:
    • Dense Breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense); or
    • At least one benign breast biopsy with a diagnosis of LCIS or atypia of any kind (atypical ductal hyperplasia, atypical lobular hyperplasia, atypical hyperplasia NOS, or intraductal papilloma with atypia); or
    • Currently on hormone therapy¹.
  • Postmenopausal women are defined as those with their last menstrual period more than 12 months prior to study entry. For the purpose of defining menopausal status for women who have had surgical cessation of their periods, women who no longer have menses due to bilateral oophorectomy with either hysterectomy or endometrial ablation will be considered postmenopausal. Women who no longer have menses due to either hysterectomy or endometrial ablation, and who have at least one ovary will be considered premenopausal until age 52 and postmenopausal thereafter.
  • All other postmenopausal women are eligible for inclusion in the biennial screening regimen.
  • For those women who cannot be assigned to annual or biennial screening at the time of study entry and randomization because they are postmenopausal, have no family history or known deleterious breast cancer mutation, are not on hormone therapy1 AND for whom a prior mammogram interpretation is not available, breast density will be determined by the radiologist’s recording of it at the time of interpretation of the first study screening examination, either DM or TM. For those who are randomized to TM, radiologists will assign BI-RADS density through review of the DM or synthetic 2D portion of the TM examination. Such women cannot be part of the planned stratification by screening frequency and are expected to represent far less than 1% of the TMIST population.
  • ¹ For this study we define hormone therapies as those that increase breast cancer risk, including: estrogen, progesterone, estrogen/progesterone analogs, or hormonal birth control prescribed by a doctor, and include hormones in oral contraceptives, patch, gel, etc. BUT, for this study, Soy use is not considered hormone therapy.
  • Breast density will be determined by prior mammography reports, when available, or by radiologist review of prior imaging.
    • NOTE: If the latter method is used, a signed, dated attestation by the radiologist indicating the resulting determination must be kept as a record and made available for monitoring/auditing.
  • All other risk factors used to determine patient eligibility for annual or biennial screening will be determined by subject self-report.
Diagnostic Test, Procedure/Surgery, Other, Digital breast tomosynthesis, Screening for malignant neoplasm of breast, Screening mammography
Breast cancer, Cancer
3D mammogram, Breast exam, Malignant tumor of breast, Mammogram, Medical Oncology
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A071801, Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS for Resected Metastatic Brain Disease (SRS FSRS)

A Study to Compare Single Fraction Stereotactic Radiosurgery Compared with Fractionated Stereotactic Radiosurgery in Treating Patients With Resected Metastatic Brain Disease

Elizabeth Yan
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100419-P01-RST
19-010587
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Inclusion Criteria:

PRE-REGISTRATION

  • Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site. Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site.
  • Three or fewer (i.e., 0 to 3) unresected brain metastases (as defined on the post operative magnetic resonance imaging [MRI]) at the time of screening.
    • Note: Dural based metastases (e.g., commonly seen in breast cancer) are eligible.
  • Unresected lesions must measure < 4.0 cm in maximal extent on the contrasted post-operative treatment MRI brain scan. The unresected lesions will be treated with SRS as outlined in the treatment section of the concept. 
    • Note: The metastases size restriction does not apply to the resected brain metastasis. 
  • One brain metastasis must be completely (gross total resection) resected ≤ 30 days prior to pre-registration. 
    • NOTE: May not have had resection of more than one brain metastasis. 
  • The resected brain metastasis must measure 2 cm or larger on the pre-operative MRI. 
  • Resection cavity must measure < 5.0 cm in maximal extent and the resection must be complete (gross total resection) on the post-operative MRI obtained ≤ 30 days prior to pre-registration. 
  • Karnofsky performance status of ≥ 60.
  • For women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to pre-registration is required. 
  • Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment. 
  • A female of childbearing potential is a sexually mature female who:
    • has not undergone a hysterectomy or bilateral oophorectomy; or 
    • has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 
  • Ability to complete an MRI of the head with contrast.
  • The brain metastasis must be located > 5 mm of the optic chiasm and outside the brain stem.
  • Must be fluent in English, Spanish, or French.

REGISTRATION

  • Completion of all baseline electronic patient-reported outcome (ePRO) quality of life measures (or booklet quality of life measures) and Montreal Cognitive Assessment (MoCA).


Exclusion Criteria:

  • Must not have any prior whole brain radiation therapy.  Past radiosurgery to other lesions is allowed. 
    • NOTE: The surgically resected lesion cannot be the same location treated in the past with radiosurgery (i.e., repeat radiosurgery to the same location/lesion is not allowed on this protocol). 
  • May not have primary germ cell tumor, small cell carcinoma, or lymphoma. 
  • No evidence of leptomeningeal metastasis (LMD). 
    • NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or equivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion.

 

Other, Procedure/Surgery, Radiation
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AGCT1531, A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors (AGCT1531)

A Study to Evaluate Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients with Germ Cell Tumors

Carola Arndt
All
up to 49 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-100462-P01-RST
19-000336
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Inclusion Criteria:
 

  • There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites]).
  • Standard risk 1: Patient must be < 11 years of age at enrollment.
  • Standard risk 2: Patients must be ≥ 11 and < 25 years of age at enrollment.
  • Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher); histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment except for those who were initially diagnosed with stage I non-seminoma malignant GCT and later recur during observation post surgery off study; for these patients, if elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart, a diagnostic biopsy is not required for enrollment
  • Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma (may contain microscopic foci of yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of MGCT); tumor markers: alpha-FP ≤ 1,000 ng/mL, beta-HCG institutional normal; all ages.
  • Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages.
  • Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages.
  • Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell Consensus Classification [IGCCC] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) < 11.
  • Standard risk 2 (SR2)
    • Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25;
    • Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x normal; age (years) ≥ 11 and < 25;
    • Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) ≥ 11 and < 25.
    • Notes:
      • IGCCC criteria only apply to SR2 patients with a testicular primary tumor;
      • Use post-op tumor marker levels to determine IGCCC risk group;
      • Stage 1 seminoma patients are not eligible for the standard risk arms of the study;
      • For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor.
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
  • Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients).
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m^2.
  • A serum creatinine based on age/gender as follows: (mg/dL):
    • 1 month to < 6 months male: 0.4 female: 0.4;
    • 6 months to < 1 year male: 0.5 female: 0.5;
    • 1 to < 2 years male: 0.6 female: 0.6;
    • 2 to < 6 years male: 0.8 female: 0.8;
    • 6 to < 10 years male: 1 female: 1;
    • 10 to < 13 years male: 1.2 female: 1.2;
    • 13 to < 16 years: male: 1.5 female: 1.4;
    • ≥ 16 years male: 1.7 female: 1.4.
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT is 45 U/L).
  • Peripheral absolute neutrophil count (ANC) ≥ 1,000/mm^3.
  • Platelet count ≥ 100,000/mm^3.
  • Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment.
  • Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes [PROs] of ototoxicity).
    • Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate.
  • ≥ 11 and < 25 years old at enrollment.
  • Able to fluently speak and read English.
  • Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor.
  • Followed for cancer or survivorship care at one of the following institutions:
    • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center;
    • Dana Farber/Harvard Cancer Center;
    • Hospital for Sick Children;
    • Children's Hospital of Eastern Ontario;
    • Oregon Health and Science University;
    • Seattle Children's Hospital;
    • Yale University.


Exclusion Criteria:

  • Patients with any diagnoses not listed including:

    • Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection);
    • Pure dysgerminoma;
    • Pure mature teratoma;
    • Pure immature teratoma COG stage I, grade I;
    • Pure immature teratoma COG stage I, grade 2,3 with alpha-fetoprotein (AFP) ≥ 1000 ng/mL;
    • Pure immature teratoma COG stage II
      •IV or FIGO stage IC to IV;
    • "Poor risk" GCT (age ≥ 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular); or
    • Primary central nervous system (CNS) germ cell tumor;
    • Germ cell tumor with somatic malignant transformation;
    • Spermatocytic seminoma.
  • Patients must have had no prior systemic therapy for the current cancer diagnosis.
  • Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage IV disease] would be considered poor risk and therefore not eligible for this trial).
  • Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin, are ineligible for the standard risk arms of the trial.
  • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients]).
  • Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients]).
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients]).

Eligibility last updated 11/29/21. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy
Cancer, Germ cell tumor
1,2-Diaminocyclohexaneplatinum II citrate, Bleomycin, Cancer treatment, Carboplatin, Chemotherapy, Etoposide, Extragonadal teratoma, Malignant germ cell tumor of ovary, Malignant germ cell tumor of testis, Medical Oncology, Reproductive system, Teratoma of ovary, bleomycin, carboplatin, cisplatin, etoposide
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MISP54450: A Phase II Study of Pembrolizumab Monotherapy in Recurrent Ovarian Cancer of the Immunoreactive Subtype Determined by NanoString Gene Expression Profiling

Pembrolizumab in Treating Participants With Recurrent Ovarian Cancer

Andrea Wahner Hendrickson
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100475-P01-RST
19-002924
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Inclusion Criteria:

  • Be willing and able to provide written informed consent/assent for the trial.
  • Be ≥ 18 years of age on day of signing informed consent.
  • Have received 1-5 prior chemotherapy lines for treating epithelial ROC (i.e., 2-6 total prior lines counting the front line).
  • Have measurable disease based on RECIST 1.1.
    • Note: Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Have a performance status of 0 or 1 on the ECOG Performance Scale.
  • Have histologically diagnosed recurrent epithelial ovarian, fallopian or primary peritoneal ovarian cancer.
  • Have provided a tumor tissue sample from an archival tissue specimen collected from the primary ovarian tumor at the time of the initial debulking surgery. If primary ovarian cancer tissue is not available alternatively non lymph node tissue from a later biopsy may be used instead.
  • Have received a tumor tissue test result of NanoString gene expression profiling that is indicative of the immunoreactive molecular subtype.
  • Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 28 days of treatment initiation.
  • Adequate Organ Function Laboratory Values:
  • Hematological
    • Absolute neutrophil count (ANC) ≥ 1,500 /mcL;
    • Platelets ≥ 100,000 / mcL;
    • Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment).
  • Renal
    • Serum creatinine OR Measured or calculated* creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤ 1.5 X upper limit of normal (ULN) OR ≥ 45 mL/min for subject with creatinine levels > 1.5 X institutional ULN.
  • Hepatic
    • Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
    • AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
    • * Creatinine clearance should be calculated per institutional standard.
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Have received front line platinum-based chemotherapy (preoperative chemotherapy is allowed).
  • Female subjects of childbearing potential must be willing to use an adequate method of contraception.  Contraception, for the course of the study through 120 days after the last dose of study medication.
    • Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.


Exclusion Criteria:
 

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks of the first dose of treatment.
  • Has had progression on or within 4 weeks of completing frontline platinum-based chemotherapy (primary platinum refractory).
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Has a known history of active TB (Bacillus Tuberculosis).
  • Hypersensitivity to pembrolizumab or any of its excipients.
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
    • Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
    • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 16. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
  • Has received a live vaccine or live-attenuated vaccine within 30 days of planned start of study therapy. Administration of killed vaccines is allowed.
    • Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

Eligibility last updated 8/31/21. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Genetic, 70-gene expression profile assay, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Cancer, Fallopian tube cancer, Ovarian cancer, Peritoneal cancer, Recurrent cancer
Biological therapy for cancer, Cancer treatment, Extraovarian primary peritoneal carcinoma, Gene expression, Malignant tumor of fallopian tube, Malignant tumor of ovary, Medical Oncology, Pembrolizumab [USAN:INN], Recurrent malignant neoplastic disease, Recurrent ovarian cancer, Reproductive system, pembrolizumab
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TNB383B.0001 - A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-383B, a Bispecific Antibody Targeting BCMA in Subjects With Relapsed or Refractory Multiple Myeloma

A Study of TNB-383B in Subjects With Relapsed or Refractory Multiple Myeloma

Shaji Kumar
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-100731-P01-RST
19-001323
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Inclusion Criteria:
 

  • Subject must be ≥ 18 years of age.
  • Three or more prior lines of therapy with exposure to a PI, an IMiD, and an anti-CD38 antibody (e.g., daratumumab). In order to be eligible for this study subjects must not be candidates for treatment regimens known to provide clinical benefit in MM.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
  • Subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent.
  • Subject must have adequate bone marrow function, defined as:
    • absolute neutrophil count (ANC) ≥ 1000/mm^3;
    • platelets ≥ 50,000/mm^3;
    • hemoglobin ≥ 8.0 g/dL;
    • Transfusion and / or growth factor support is permitted prior to assessment, but neutrophils, platelets, and hemoglobin must be stable for at least 72 hours after transfusion and / or growth factor administration prior to Screening for the subject to be eligible.
  • Subject must have an eGFR ≥ 30 mL/min as estimated by the MDRD formula.
  • Subject must have total bilirubin ≤ 1.5 × upper limit of normal (ULN; except if the subject has a known diagnosis of Gilbert’s syndrome, in which case bilirubin must be < 3 x ULN).
  • Serum calcium (corrected for albumin) at or below the ULN range (subject may enroll in the setting of hypercalcemia at Screening IF hypercalcemia resolves with standard treatment by Cycle 1 Day 1) prior to study therapy initiation.
  • Measurable Disease: Subject has a diagnosis of MM and documented prior treatment with a PI, an IMiD, and an anti-CD38 mAb (ie, daratumumab) as part of 3 or more lines of therapy. In order to be eligible for this study subjects must not be candidates for treatment regimens known to provide clinical benefit in MM. There is no maximum number of prior regimens and prior bone marrow transplant is acceptable if subject is > 12 weeks (autologous) or > 1 year (allogeneic) status-post transplantation.
  • Measurable disease is defined as at least 1 of the following:
    • Serum M-protein ≥ 0.5 g/dL (≥ 5 g/L);
    • Urine M-protein ≥ 200 mg / 24h;
    • Serum free light chain (FLC) assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/L) and an abnormal serum FLC ratio (< 0.26 or > 1.65).
  • Subject has confirmed evidence of relapse / progression from the immediately prior MM therapy, or subject is relapsed / refractory to the immediately prior MM therapy. (‘Refractory’ is defined as subjects with either progressive disease or best response of stable disease to the last therapy; ‘Relapsed / refractory’ is defined as subjects with a history of minimal response [MR] or better response to prior therapy, now with disease progression within 60 days of the last therapy. ‘Relapse’ is defined as previously treated myeloma that progresses and requires initiation of salvage therapy, without meeting IMWG uniform response criteria for relapsed / refractory).
  • Subject has adequate archival tumor bone marrow tissue if available or consents to a fresh pre- treatment bone marrow tumor biopsy.


Exclusion Criteria:

  • Subject has been diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of basal cell or squamous cell carcinoma of the skin, in situ malignancy, low-risk prostate carcinoma after curative therapy, or complete resection / curative therapy of an advanced malignancy.
  • Subject has a history of central nervous system (CNS) involvement by their myeloma.
  • Subject has a history of Grade ≥ 3 peripheral neuropathy.
  • Subject has a history of plasma cell leukemia, POEMS syndrome, or amyloidosis.
  • Subject has received another investigational drug within 21 days of enrollment.
  • Subject has ever received BCMA-targeted therapy. Subjects who have received targeted therapy against non-BCMA targets will not be excluded.
  • Subject has received a peripheral autologous stem cell transplant within 12 weeks or an allogeneic stem cell transplant within 1 year of the first dose of study drug treatment.
  • Subject has any medical or psychiatric condition which in the opinion of the investigator or Study Medical Monitor places the subject at an unacceptably high risk for toxicities, could interfere with successful or safe delivery of therapy, or could interfere with evaluation of the investigational product or interpretation of subject safety or study results. Examples include history of significant mucosal / internal bleeding, major psychiatric illness, drug abuse (including active alcoholism), or known allergy or hypersensitivity to components of the study drug formulation.
  • Subject has received any therapy to treat cancer (including radiation, chemotherapy, biologics, cellular therapies and / or steroids at doses > 20 mg dexamethasone or equivalent) or undergone a major surgical procedure within 21 days, or within 5 half-lives of an anti-cancer drug, prior to the first dose of study treatment, whichever is shorter.
  • Subject has known infection Grade ≥ 2 requiring anti-infective treatment. Upon completion of antibiotics and resolution to Grade ≤ 1, the subject is considered eligible for the study from an infection standpoint.
  • Confirmed positive test results for human immunodeficiency virus (HIV), or subjects with chronic or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). Subjects who have a history of HBV or HCV who have documented cures (HBV: hepatitis B surface antigen [HBsAg] negative; HCV: undetectable HCV RNA 24 weeks after the end of treatment) may be enrolled.
  • Major cardiac abnormalities such as but not limited to the following: uncontrolled angina or unstable life-threatening arrhythmias, history of myocardial infarction ≤ 12 weeks before Screening, Class ≥ 3 New York Heart Association congestive heart failure, severe cardiac insufficiency, or persistent QTc prolongation (> 480 msec, QTc Fridericia).
  • If female, subject must not be pregnant or breastfeeding and be either postmenopausal (for at least 12 consecutive months), OR permanently surgically sterile OR for women of childbearing potential practicing at least 1 protocol specified method of female birth control AND 1 protocol specified method of male birth control (vasectomy or condoms), starting at Screening through at least6 months after the last dose of study drug.
  • Subject has unresolved AEs ≥ Grade 2 (NCI CTCAE v5.0) from prior anticancer therapy except for:
    • Alopecia;
    • Peripheral neuropathy (peripheral neuropathy ≥ Grade 3 will be excluded);
    • Anemia or thrombocytopenia (the latter cytopenias must be Grade 4 to trigger exclusion, Grade 3 with symptoms or bleeding, respectively, or return within 72 hours despite transfusion support);
    • Subjects with irreversible toxicity not reasonably expected to be exacerbated by any of the investigational products may be included (e.g., hearing loss) after consultation with the Study Medical Monitor.

Eligibility last updated 2/11/22. Questions regarding updates should be directed to the study team contact.

Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Multiple myeloma
Cancer treatment, Hematopoietic system, Medical Oncology, Relapse multiple myeloma
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Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

A Study of Standard Systemic Therapy with or without Definitive Treatment in Treating Participants with Metastatic Prostate Cancer

Matthew Tollefson
Male
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100794-P01-RST
19-000597
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Inclusion Criteria:
 

STEP 1 REGISTRATION
•DISEASE-RELATED CRITERIA

  • All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Patients with pure small cell carcinoma* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible. (*morphology must be consistent with SCC; synaptophysin or chromogranin positive by immunohistochemical staining is insufficient to diagnose SCC).
  • Patients must have an intact prostate.
  • Patients must have at least one of the following scans performed, showing evidence of metastatic disease:
    • technetium bone scan; OR
    • CT of abdomen & pelvis; OR
    • MRI of pelvis..
  • Scans must be performed between 42 days prior to start of first hormonal therapy and 14 days following start of first hormonal therapy. Metastatic disease that is detected by PET scan only (NaF, PSMA, FACBC, C11) but not conventional imaging (Tc99 bone scan, CT or MRI) or solitary metastases by conventional imaging, must be confirmed histologically or cytologically.
  • Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease.

STEP 1 REGISTRATION
•PRIOR/CONCURRENT THERAPY CRITERIA

  • Patients must have received no more than 28 weeks of SST, as measured from the date of first hormonal therapy (LHRH agonist or LHRH antagonist) or surgical castration. SST is defined as current NCCN guidelines for metastatic prostate cancer.
  • No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, HIFU, cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation).
  • Patients must not have received any prior systemic therapy for prostate cancer, outside of line of SST to be used for duration of study.
  • Patients must not have progressed while on SST.
  • Patients with oligometastatic prostate cancer may receive metastasis directed therapy to up to four sites of disease prior to randomization.

STEP 1 REGISTRATION
•CLINICAL/LABORATORY CRITERIA:

  • Patients must be ≥ 18 years of age.
  • Patients must have a complete physical examination and medical history within 28 days prior to registration.
  • Patients must have a documented PSA:
    • Prior to initiation of SST;
    • Within 28 days prior to registration;
    • Any additional PSAs measured while receiving SST should be recorded.
  • Patients must have a testosterone lab documented within 28 days prior to registration. Any additional testosterone labs measured while receiving SST should be recorded as well as pretreatment initiation if available.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.

STEP 1 REGISTRATION
•SPECIMEN SUBMISSION CRITERIA

  • Patients must be offered the opportunity to participate in translational medicine studies and specimen banking for future studies.

STEP 1 REGISTRATION - QUALITY OF LIFE CRITERIA

  • Patients who can complete Patient-Reported Outcome instruments in English, Spanish or French, must participate in the quality of life studies.

STEP 1 REGISTRATION - REGULATORY CRITERIA

  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  • As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

STEP 2 RANDOMIZATION
•DISEASE-RELATED CRITERIA

  • Patients must have no evidence of disease progression during the 28 weeks of SST, as shown by:
    • PSA measure;
    • imaging (bone scan and one of the following: CT of abdomen & pelvis, MRI of abdomen & pelvis, CT of abdomen & MRI of pelvis) within 42 days prior to randomization.
  • Patients must have no evidence of symptomatic deterioration (as defined by physician discretion) within 28 days prior to randomization.
  • Patients must have consultation with a urologist and have surgically resectable disease regardless of definitive treatment intent or randomization.

STEP 2 RANDOMIZATION - PRIOR/CONCURRENT THERAPY CRITERIA

  • Patients must have received at least 22 and no more than 28 weeks of SST, as measured from the date of first hormonal therapy (LHRH agonist or LHRH antagonist) or surgical castration. SST is defined by current NCCN guidelines for metastatic prostate cancer.
  • Patients must not be planning to receive docetaxel after randomization.
  • Any toxicities from SST must have resolved to ≤ Grade 1 (CTCAE Version 5.0) prior to randomization.
  • Patients may have received elective metastasis directed therapy to oligometastatic sites (≤ 4 sites). All treatment must be completed prior to randomization.

STEP 2 RANDOMIZATION - CLINICAL/LABORATORY CRITERIA

  • Patients must have a PSA performed within 28 days prior to randomization.
  • Patients must have a testosterone < 50 ng/dL within 28 days prior to randomization.
  • Patients must have a Zubrod performance status of 0 – 1 within 28 days prior to randomization.
Drug, Other, Procedure/Surgery, Radiation, Prostate destructive procedure, Radiation therapy procedure or service
Cancer, Prostate cancer
Adenocarcinoma of prostate, Cancer treatment, Medical Oncology, Radiation therapy, Reproductive system
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A Phase 1b Study of Berzosertib in Combination With Radiation Therapy to Overcome Therapeutic Resistance in Chemotherapy Resistant Triple Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer

A Study to Test the Addition of berzosertib to Usual Radiation Treatment for Chemotherapy-Resistant Breast Cancer

Robert Mutter
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-100827-P01-RST
19-012508
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Inclusion Criteria:

  • Males or females age ≥ 18 years
  • Patient has non-metastatic, histologically confirmed primary or locoregionally recurrent estrogen receptor (ER) ≤ 10%, progesterone receptor (PR) ≤ 10%, and HER2-negative breast cancer (triple negative breast cancer [TNBC]) either using the baseline biopsy specimen or the post-neoadjuvant chemotherapy (NAC) residual surgical specimen and residual cancer burden (RCB)2 or RCB3, as defined by Symmans et al., 2007, and received neoadjuvant anthracycline and/or taxane-based chemotherapy OR patient has non-metastatic, histologically confirmed primary ER > 10% and/or PR > 10%, HER2-negative breast cancer with RCB3 and received neoadjuvant anthracycline and/or taxane-based chemotherapy OR patient has locoregionally recurrent TNBC or ER > 10% and/or PR > 10%, HER2-negative breast cancer.
    • Note: The RCB can be calculated at http://www3.mdanderson.org/ap/medcalc/index.cfm?pagename=jsconvert2
    • Note: Results from any CLIA-certified lab are acceptable for the purpose of determining study eligibility.
    • Note: For patients with primary breast cancer, there is no minimum number of neoadjuvant cycles required provided the patient received an anthracycline or taxane preoperatively. Patients with locoregionally recurrent breast cancer are not required to have received preoperative chemotherapy.
  • Patient has undergone total mastectomy or wide local excision with axillary staging, and the margins of the resected wide local excision or mastectomy specimens are free of invasive tumor and ductal carcinoma in situ (DCIS) or patient has undergone axillary surgery for regionally recurrent breast cancer. Unresected axillary level III, internal mammary, and supraclavicular nodal disease is permitted.
    • Note: For patients who have undergone mastectomy, immediate reconstruction is allowed.
  • Patients must have completed their final breast surgery including re-excision of margins for invasive cancer and DCIS, or received their last adjuvant chemotherapy infusion,  within 90 but not fewer than 21 days prior to registration unless patient received postoperative chemotherapy in which case patients must have completed their adjuvant chemotherapy within 90 days but not fewer than 28 days prior to registration. but no sooner than 21 days prior to the initiation of RT for surgery or 28 days for chemotherapy. Post-radiotherapy adjuvant systemic therapy (e.g. adjuvant capecitabine) may not be completed less than 21 days prior to the first fraction of RT or begin less than 28 days from the last fraction of RT.
  • Patient must have recovered from surgery with the incision completely healed and no signs of infection prior to registration.
  • Patients must be proceeding with breast/chest wall and regional nodal irradiation including internal mammary node treatment. BFor patients with bilateral breast cancer is permitted provided that , RT ismust be indicated and administered only to one side.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Willing to provide tissue and blood samples for correlative research:
    • Leukocytes ≥ 3,000/mcL;
    • Absolute neutrophil count ≥ 1,500/mcL;
    • Platelets ≥ 100,000/mcL;
    • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN);
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 x institutional ULN;
    • Creatinine ≤ institutional ULN; OR
    • Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2 for patients with creatinine levels above ULN.
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Negative urine or serum pregnancy test for individuals of childbearing potential.
    • Note: The effects of berzosertib on the developing human fetus are unknown. For this reason and because DNA-damage repair inhibitors as well as radiation used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and for 6 months after completion of M6620 administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.  Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of berzosertib administration.
  • Ability to understand and the willingness to sign a written informed consent document.


Exclusion Criteria:

  • Patients who have had chemotherapy within 4 weeks prior to entering the study.
  • Prior RT to the ipsilateral chest wall or ipsilateral breast or thorax. Individuals with prior RT to the contralateral breast or chest wall are eligible.
  • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia and grade 1-2 taxane-induced neuropathy which will be permitted.
  • Patients who are receiving any other investigational agents or concomitant anti-neoplastic treatment, except endocrine therapies and bisphosphonates which are permitted without restriction even during protocol treatment. Postoperative chemotherapy is allowed but must be discontinued >28 days prior to registration.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to berzosertib.
  • Berzosertib is primarily metabolized by CYP3A4; therefore, concomitant administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir, and saquinavir) or inducers of CYP3A4 (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, St. John's wort) should be avoided. Patients requiring any medications or substances that are strong inhibitors or inducers of CYP3A during the course of the study and for 14 days prior to enrollment are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
  • Patients with uncontrolled intercurrent illness. This includes but is not limited to, ongoing uncontrolled serious infection requiring IV antibiotics at the time of registration, symptomatic congestive heart failure, unstable angina pectoris, symptomatic/uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Active systemic lupus, scleroderma, or dermatomyositis with a CPK level above normal.
  • Pregnant women are excluded from this study because berzosertib as a DNA damage repair inhibitor may have the potential for teratogenic or abortifacient. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with berzosertib, breastfeeding should be discontinued if the mother is treated with berzosertib.
  • Patients with known hereditary syndromes predisposing to radiosensitivity such as Li Fraumeni syndrome and ataxia telangiectasia are excluded from the study. Patients with mutations in breast cancer predisposition genes such as BRCA1, BRCA2, PALB2, CHEK2, and ATM are eligible.
  • Patients with a prior or concurrent malignancy, excluding non-melanoma skin cancers and non-invasive cancers whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.
Drug, Other, Radiation, Administration of antineoplastic agent, Drug therapy, Excision of lesion of breast, Radiotherapy to breast
Breast cancer, Cancer, Triple-negative breast cancer
Berzosertib [USAN], Cancer treatment, Estrogen receptor positive tumor, Hormone receptor positive malignant neoplasm of breast, Human epidermal growth factor 2 negative carcinoma of breast, Medical Oncology, Progesterone receptor positive tumor, Radiation therapy, Radiation therapy for breast cancer, Triple-negative breast cancer
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19380 - An Open-Label, Multi-Institutional Pilot Study to Assess the Use of Glucarpidase in Adult Patients With Osteosarcoma Receiving High-Dose Methotrexate

Glucarpidase After High-Dose Methotrexate in Patients With Osteosarcoma

Brittany Siontis
All
25 years and over
Early Phase 1
This study is NOT accepting healthy volunteers
0000-100828-P01-RST
19-003941
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Inclusion Criteria:

  • All races and ethnic groups will be eligible.
  • High-risk individuals aged ≥ 40 years. 
  • Eastern Cooperative Oncology Group (ECOG) performance score 0-2.
  • Participants must have pathologically confirmed diagnosis of osteosarcoma. Participants must be newly diagnosed and previously untreated, although initiation of doxorubicin/cisplatin prior to enrollment is permitted.
  • Participants must have a recommended treatment plan for their osteosarcoma that includes:
    • Planned MTX treatment at 8-12 g/m^2;
    • Absolute neutrophil count (ANC) ≥ 1,000/mm^3 (or ≥ 1.0 x 10^9/L);
    • Platelet count 75,000/mm^3 (or ≥ 75 x 10^9/L);
    • Hemoglobin ≥ 8 g/dL;
    • Serum creatinine ≤ 1.5 x the upper limit of normal (ULN), or glomerular filtration rate (GFR) ≥ 60 ml/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease (MDRD) formula;
    • Total serum bilirubin ≤ 2 x ULN;
    • Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5 x ULN.
  • Participants must be willing to use appropriate contraception for the duration of study treatment and four months after completing HDMTX therapy.
  • Ability to understand and the willingness to sign a written informed consent document.


Exclusion Criteria:

  • Malignant disease, other than those being treated in this study. Exceptions to this exclusion include the following:
    • Malignancies that were treated curatively and have not recurred within 2 years after completion of treatment;
    • Completely resected basal cell and squamous cell skin cancers;
    • Any malignancy considered to be indolent and that has never required therapy;
    • Completely resected carcinoma in situ of any type.
  • Participants with rapidly progressive disease or organ dysfunction that would prevent them from receiving planned HDMTX treatment regimen.
  • Previous MTX treatment at doses >= 3 g/m^2.
  • Previous treatment with glucarpidase.
  • Known clinically significant liver disease defined as ongoing drug-induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, portal hypertension, or history of autoimmune hepatitis.
  • Patients who have completed curative therapy for HCV are eligible.
  • Patients with known history of human immunodeficiency virus (HIV) infection are eligible.
  • Participants with a history of hypersensitivity reactions to study agent or its excipients.
  • Participants with a history of hypersensitivity to Escherichia (E).coli-derived proteins.
  • Participants with large pleural or ascitic fluid collection.
  • Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
  • Uncontrolled intercurrent illness, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  • Unable or unwilling to discontinue use of agents that interact significantly with methotrexate metabolism or excretion.
Drug, Other, Administration of antineoplastic agent, Drug therapy
Bone cancer, Cancer, Osteosarcoma, Sarcoma
Cancer treatment, Medical Oncology, Methotrexate, Musculoskeletal system, Osteosarcoma of bone, gamma-Glutamyl hydrolase, glucarpidase, methotrexate
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TRANSCEND CLL 004 - An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)

A Study Evaluating the Safety and Effectiveness of JCAR017 to Treat Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Saad Kenderian
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-100830-P01-RST
19-001564
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Inclusion Criteria:
 

  • Age ≥ 18 years at the time of consent.
  • Signed written informed consent.
  • JCAR017 monotherapy and ibrutinib + JCAR017 combination cohorts must have diagnosis of:
    • CLL with an indication for treatment based on the Investigator’s opinion and measurable disease (any of the following: bone marrow involvement by ≥ 30% lymphocytes, peripheral blood lymphocytosis > 5 × 10^9 /L, and/or measurable lymph nodes ≥ 1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly); or
    • SLL (lymphadenopathy and/or splenomegaly and < 5 × 10^9 CD19+ CD5+ clonal B lymphocytes/L [< 5000/µL] in the peripheral blood at diagnosis with measurable disease defined as at least one lesion ≥ 1.5 cm in the greatest transverse diameter) that is biopsy-proven SLL Venetoclax + JCAR017 combination cohorts must have diagnosis of:
    • CLL or SLL with an indication for treatment based on the Investigator’s opinion and measurable disease (any of the following: measurable lymph nodes ≥ 1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly), and demonstration of CLL cells in the peripheral blood by flow cytometry.
  • Subjects (other than those in the ibrutinib + JCAR017 combination therapy cohort) must have received and failed BTKi treatment or have been deemed ineligible for BTKi therapy due to requirement for full dose anticoagulation or history of arrhythmia. Failure to BTKi is defined as having stable disease or progressive disease (PD) as best response, or progression after previous response, or discontinuation due to intolerance. Intolerance is defined as failure to tolerate treatment due to unmanageable toxicity.
  • Subjects in the JCAR017 monotherapy cohorts must have received previous treatment as follows:
    • Subjects with CLL or SLL and high-risk features, defined as having complex cytogenetic abnormalities (3 or more chromosomal abnormalities), 17p deletion, TP53 mutation, or unmutated immunoglobulin heavy chain variable region (IGHV), must have failed at least 2 lines of prior therapy;
    • Subjects with CLL or SLL and standard-risk features must have failed at least 3 lines of prior therapy.
  • Subjects in the ibrutinib + JCAR017 combination cohorts must either:
    • be receiving ibrutinib, or other BTKi, and progressing at the time of study enrollment; or
    • be receiving ibrutinib, or other BTKi, for at least 6 months with a response less than CR and have high-risk features, as defined in inclusion criterion 5a; or
    • have BTK or phospholipase C gamma 2 (PLCγ2) mutations per local laboratory assessment, with or without progression on ibrutinib; or
    • have previously received ibrutinib, or other BTKi, and have no contraindications to initiate or reinitiate ibrutinib (i.e., ibrutinib was not discontinued due to intolerability and subject has no medical contraindications such as arrhythmia or need for anticoagulation) Subjects in the ibrutinib + JCAR017 combination therapy cohorts enrolled under at least amendment 5, must also meet the below criteria:
    • have progressed on a BTKi and f. have received prior therapy with venetoclax which is considered if they meet one of the following criteria:
      • the subject continued on venetoclax due to disease progression or intolerability and if the subject’s disease met indications for further therapy per iwCLL 2018 criteria; or
      • the subject failed to achieve an objective response within 3 months of initiating therapy. Subjects in the venetoclax + JCAR017 combination cohorts must:
    • Have failed at least 1 prior line of therapy, including having failed BTKi therapy or have been deemed ineligible to receive BTKi, as defined in Inclusion Criterion #4;
    • Be venetoclax naïve (required for dose expansion cohort); or
      • If prior venetoclax, (only for dose escalation cohort) (1) have no contraindications to reinitiation of venetoclax based on prior intolerance and (2) have had at least 6 months elapsed since the last dose of venetoclax, if either of the following criteria are met:
      • the best response was stable disease; or
      • the subject experienced disease progression on venetoclax within 6 months of venetoclax discontinuation.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
  • Assessed by the Investigator to have adequate bone marrow function to receive lymphodepleting chemotherapy.
  • Adequate organ function, defined as:
    • Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance (Cockcroft and Gault) > 30 mL/min;
    • Alanine aminotransferase (ALT) ≤ 5 × ULN and total bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with Gilbert’s syndrome or leukemic infiltration of the liver);
    • Adequate pulmonary function, defined as ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 dyspnea and saturated oxygen (SaO2) ≥ 92% on room air;
    • Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 40% as assessed by echocardiogram (ECHO) or multiple uptake gated acquisition (MUGA) scan performed within 30 days prior to determination of eligibility Subjects in the venetoclax + JCAR017 combination dose escalation and expansion cohorts must have:
      • Hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 500/mm^3 , and platelets ≥ 75,000/mm^3 , unless cytopenias judged by the Investigator to be due to CLL infiltration of the bone marrow.
  • Subject either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure.
  • If prior CD19-targeted therapy has been administered, subject must have CD19-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD19-targeted therapy.
  • Females of childbearing potential must either commit to true abstinence from heterosexual contact or agree to use one highly effective method of contraception from screening until at least 1 year after receiving lymphodepleting chemotherapy.
  • Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (ß-hCG) pregnancy test result at screening and within 48 hours prior to the first dose of lymphodepleting therapy.
  • Males who have partners of childbearing potential must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 1 year after receiving lymphodepleting chemotherapy even if he has undergone a successful vasectomy.


Exclusion Criteria:

  • Subjects with known active central nervous system (CNS) involvement by malignancy. Subjects with prior CNS disease that has been effectively treated will be eligible if treatment was completed at least 3 months prior to enrollment with no evidence of symptomatic disease and stable abnormalities on repeat imaging.
  • History of another primary malignancy that has not been in remission for at least 2 years. (The following are exempt from the 2-year limit: nonmelanoma skin cancer, completely resected stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.).
  • Subjects with Richter’s transformation.
  • Prior treatment with any gene therapy product.
  • Active hepatitis B, or active hepatitis C (Subjects with a negative polymerase chain reaction (PCR) assay for viral load for hepatitis B or C are permitted; subjects positive for hepatitis B surface antigen and/or anti-hepatitis B core antibody with negative viral load are eligible and should be considered for prophylactic antiviral therapy), or history of or active human immunodeficiency virus (HIV) infection.
  • Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
  • Presence of acute or extensive chronic graft versus host disease (GVHD).
  • History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease.
  • History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, cerebral edema, or psychosis.
  • Pregnant or nursing (lactating) women.
  • Use of any of the following medications or treatments within the noted time prior to leukapheresis:
    • Alemtuzumab within 6 months prior to leukapheresis;
    • Allogeneic hematopoietic stem cell transplant within 100 days prior to leukapheresis;
    • Cladribine within 3 months prior to leukapheresis;
    • Donor lymphocyte infusions (DLI) within 2 months prior to leukapheresis;
    • Radiation including large bone marrow fields such as sternum or pelvis within 6 weeks prior to leukapheresis;
    • Fludarabine within 4 weeks prior to leukapheresis;
    • GVHD therapies such as calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, or immunosuppressive antibodies (such as anti-tumor necrosis factor-α [TNFα], anti-interleukin-6 [IL-6], or anti-interleukin-6 receptor [IL-6R]) within 4 weeks prior to leukapheresis;
    • Cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan within 2 weeks prior to leukapheresis;
    • Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis;
    • Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis;
    • Venetoclax within 4 days prior to leukapheresis;
    • Idelalisib or duvelisib within 2 days prior to leukapheresis;
    • Lenalidomide or acalabrutinib within 1 day prior to leukapheresis;
    • Experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis unless progression is documented on the experimental therapy and at least 3 halflives have elapsed prior to leukapheresis.
  • Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol.
  • Progressive vascular tumor invasion, thrombosis, or embolism.
  • Venous thrombosis or embolism requiring treatment but not managed on a stable regimen of anticoagulation.
  • For subjects in the venetoclax + JCAR017 combination cohorts only, concomitant treatment with CYP3A moderate/strong inducers or moderate/strong inhibitors which cannot be discontinued.
Biologic/Vaccine, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Cancer, Chronic lymphocytic leukemia, Leukemia, Lymphoma, Non-Hodgkin's lymphoma
Biological therapy for cancer, Cancer treatment, Chronic lymphoid leukemia, disease, Hematopoietic system, Malignant lymphoma - small lymphocytic, Medical Oncology, Cellular therapy
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A Pilot Study Evaluating the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients After Radiation Therapy for Central Nervous System Tumors

A Study to Evaluate the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients After Radiation Therapy for Central Nervous System Tumors

Nadia Laack
All
4 years to 18 years old
Early Phase 1
This study is NOT accepting healthy volunteers
0000-100836-P01-RST
19-004245
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Inclusion Criteria:

  • Age ≥ 4 years to ≤ 18 years old.
  • Receiving intracranial radiation for a primary CNS malignancy.
  • Histological or radiologic confirmation of intracranial disease.
  • Able to use the computer for CogState assessment battery.
  • Serum creatinine and total bilirubin obtained ≤ 35 days prior to study entry, with adequate kidney and liver function defined as follows:
    • Normal serum creatinine per institutional normal limits;
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) OR Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 x ULN, Aspartate transaminase (AST) AND alanine transaminase (ALT) ≤ 2.5 x ULN.
  • Provide informed consent if over age 18, or provide assent with consent from parent or legal guardian if age 7-17.
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only. Patients capable of childbearing must use adequate contraception.


Exclusion Criteria:

  • Patients with WHO Grade IV astrocytoma or glioblastoma tumors.
    • Note: A patient with Grade IV tumors of other histology can participate in the study if they meet all other criteria.
  • Any prior intracranial radiation.
  • Any contraindication or allergy to memantine.
  • Use of short-acting benzodiazepines (may excite lethargy/dizziness with memantine).
    • Note: occasional use as a sleep aid or as needed  for anxiety or nausea is allowed.
  • Intractable seizures while on adequate anticonvulsant therapy, defined as more than one seizure per month for the past 2 months.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

 

Drug, Drug therapy, Radiation oncology AND/OR radiotherapy, Radiotherapy to head
Brain tumor, Cancer, Cognitive impairment, Pediatric brain tumor
Cancer treatment, Impaired cognition, Malignant neoplasm of central nervous system, Medical Oncology, Memantine, Nervous system, Radiation therapy, memantine
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ROR1904: A Comparison of Acute Toxicities between Patients Treated with Protons or Intensity-Modulated Radiation Therapy for Post-Operative Treatment of Endometrial or Cervical Cancers

A Study to Compare Acute Toxicities between Patients Treated with Protons or Intensity-Modulated Radiation Therapy for Post-Operative Treatment of Endometrial or Cervical Cancers

Ivy Petersen
All
18 years and over
Early Phase 1
This study is NOT accepting healthy volunteers
0000-100837-P01-RST
19-004792
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Inclusion Criteria:

    •  
  • Age ≥ 18 years old.
  • Histologically confirmed diagnosis of cervical or endometrial cancer..
  • Must have undergone an open or robotic hysterectomy (total abdominal, vaginal, radical, or total laparoscopic) for carcinoma of the cervix or endometrium.
  • History and physical prior to registration.
  • Documentation of history of:
    • Smoking status;
    • Pelvic infection;
    • Pelvic Inflammatory Disease;
    • Endometriosis.            
  • Planned to receive either proton or Intensity-Modulated Radiation Therapy (IMRT) radiation treatment, with use of rectal balloon, at an IRB-approved Mayo Clinic site.
  • Plan for radiation therapy (RT) to pelvis with or without para-aortic lymph node irradiation.
  • If received high-dose chemotherapy prior to registration, last dose must have been given ≥ 21 days prior to start of RT .       
  • CBC performed within 21 days prior to registration.
  • CT, MRI, PET/CT, or PET/MRI for staging before registration; may be pre-op or post-op.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2.
  • Provide written informed consent.
  • Willing to complete QOL questionnaires.


Exclusion Criteria:
 

  • Receiving external beam boost dose during RT.
  • Distant metastases.
  • No gross disease at time of RT.
  • Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma or small cell carcinomas.
  • Patients who exceed the weight/size limits of the treatment table.
  • Patients with active irritable bowel disease.
  • Positive or close surgical margins (≤ 3 mm).
  • Prior RT to the pelvis.
  • Planned to receive inguinal node RT.
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note that HIV testing is not required for entry into this protocol.  The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be immunosuppressive.
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
      • Severe, active co-morbidity defined as follows:
        • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
        • Transmural myocardial infarction within the last 6 months;
        • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
      • Other major medical illness which requires hospitalization or precludes study therapy at the time of registration.
  • Patients unwilling to have rectal balloon placed on a daily basis during RT.
Behavioral, Radiation
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MC19C1, Rose Geranium in Sesame Oil Nasal Spray as an Agent to Improve Symptoms of Nasal Vestibulitis: A Phase III Double Blinded Randomized Controlled Trial (MC19C1)

Rose Geranium in Sesame Oil Nasal Spray for the Improvement of Nasal Vestibulitis Symptoms in Cancer Patients Receiving Chemotherapy

Charles Loprinzi
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100863-P01-RST
19-006677
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Registration
•Inclusion Criteria

  • Age ≥ 18 years.
  • Diagnosed with cancer and receiving chemotherapy.
  • Able to provide informed consent.
  • Willingness to complete questionnaires.
  • ECOG Performance Status (PS) 0, 1, 2.
  • One or more of the following nasal symptoms for which the patient reports they would appreciate treatment. Symptoms must have started after the initiation of systemic, antineoplastic therapies, be attributed to the systemic, antineoplastic therapies, and symptoms must be reported  as being moderate (corresponding to a score of 2) or worse on a scale from mild (1) to very severe (4) on at least one of the items below.
  • Dryness;
  • Discomfort/Pain;
  • Bleeding;
  • Scabbing;
  • Sores.

 Registration


Exclusion Criteria:

  • Predisposition to epistaxis prior to the initiation of cancer-directed therapy (more than once a month over the previous year).
  • Planned initiation or continuation of any topical nasal treatment other than the studied nasal spray,( such as nasal steroids, Ayr nasal gel, Neosporin ointment or nasal administration of petroleum jelly).  Taking Imitrex for migraines is acceptable.
  • Previous exposure to rose geranium in sesame oil nasal spray.
  • Concurrent upper respiratory tract infection.
  • History of allergic or other adverse reactions to sesame oil or essential rose geranium oil.
  • Any other reason that the study clinician or investigator feels precludes safe or appropriate inclusion in this study.

Re-Registration:

  • The patient will be un-blinded and determined to have been on the saline arm, when initially randomized.
Drug
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Mayo Clinic — Rochester, MN

MC19C1, Rose Geranium in Sesame Oil Nasal Spray as an Agent to Improve Symptoms of Nasal Vestibulitis: A Phase III Double Blinded Randomized Controlled Trial (MC19C1)

Rose Geranium in Sesame Oil Nasal Spray for the Improvement of Nasal Vestibulitis Symptoms in Cancer Patients Receiving Chemotherapy

Stephan Thome
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100863-P01-MAIJ
19-006677
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Registration
•Inclusion Criteria

  • Age ≥ 18 years.
  • Diagnosed with cancer and receiving chemotherapy.
  • Able to provide informed consent.
  • Willingness to complete questionnaires.
  • ECOG Performance Status (PS) 0, 1, 2.
  • One or more of the following nasal symptoms for which the patient reports they would appreciate treatment. Symptoms must have started after the initiation of systemic, antineoplastic therapies, be attributed to the systemic, antineoplastic therapies, and symptoms must be reported  as being moderate (corresponding to a score of 2) or worse on a scale from mild (1) to very severe (4) on at least one of the items below.
  • Dryness;
  • Discomfort/Pain;
  • Bleeding;
  • Scabbing;
  • Sores.

 Registration


Exclusion Criteria:

  • Predisposition to epistaxis prior to the initiation of cancer-directed therapy (more than once a month over the previous year).
  • Planned initiation or continuation of any topical nasal treatment other than the studied nasal spray,( such as nasal steroids, Ayr nasal gel, Neosporin ointment or nasal administration of petroleum jelly).  Taking Imitrex for migraines is acceptable.
  • Previous exposure to rose geranium in sesame oil nasal spray.
  • Concurrent upper respiratory tract infection.
  • History of allergic or other adverse reactions to sesame oil or essential rose geranium oil.
  • Any other reason that the study clinician or investigator feels precludes safe or appropriate inclusion in this study.

Re-Registration:

  • The patient will be un-blinded and determined to have been on the saline arm, when initially randomized.
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Mayo Clinic Health System — Mankato, MN

MC19C1, Rose Geranium in Sesame Oil Nasal Spray as an Agent to Improve Symptoms of Nasal Vestibulitis: A Phase III Double Blinded Randomized Controlled Trial (MC19C1)

Rose Geranium in Sesame Oil Nasal Spray for the Improvement of Nasal Vestibulitis Symptoms in Cancer Patients Receiving Chemotherapy

Mina Hanna
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100863-P01-ALCL
19-006677
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Registration
•Inclusion Criteria

  • Age ≥ 18 years.
  • Diagnosed with cancer and receiving chemotherapy.
  • Able to provide informed consent.
  • Willingness to complete questionnaires.
  • ECOG Performance Status (PS) 0, 1, 2.
  • One or more of the following nasal symptoms for which the patient reports they would appreciate treatment. Symptoms must have started after the initiation of systemic, antineoplastic therapies, be attributed to the systemic, antineoplastic therapies, and symptoms must be reported  as being moderate (corresponding to a score of 2) or worse on a scale from mild (1) to very severe (4) on at least one of the items below.
  • Dryness;
  • Discomfort/Pain;
  • Bleeding;
  • Scabbing;
  • Sores.

 Registration


Exclusion Criteria:

  • Predisposition to epistaxis prior to the initiation of cancer-directed therapy (more than once a month over the previous year).
  • Planned initiation or continuation of any topical nasal treatment other than the studied nasal spray,( such as nasal steroids, Ayr nasal gel, Neosporin ointment or nasal administration of petroleum jelly).  Taking Imitrex for migraines is acceptable.
  • Previous exposure to rose geranium in sesame oil nasal spray.
  • Concurrent upper respiratory tract infection.
  • History of allergic or other adverse reactions to sesame oil or essential rose geranium oil.
  • Any other reason that the study clinician or investigator feels precludes safe or appropriate inclusion in this study.

Re-Registration:

  • The patient will be un-blinded and determined to have been on the saline arm, when initially randomized.
Drug
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Mayo Clinic Health System — Albert Lea, MN

EA9171, BLAST MRD CML 1 Trial: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease (MRD) in Chronic Myeloid Leukemia (CML) - A Phase II Study of Adding the Anti-PD-1 Pembrolizumab to Tyrosine Kinase Inhibitors in Patients With CML and Persistently Detectable MRD

A Study to Evaluate Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients with Chronic Myeloid Leukemia and Persistently- Detectable Minimal Residual Disease

Mark Litzow
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100877-P01-RST
19-002029
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Inclusion Criteria:
 

PREREGISTRATION (STEP 0)

  • Age ≥ 18 years.
  • Patient has pathologically-confirmed chronic phase-CML one of the following the following criteria:
    • Patient has been in MMR (i.e. MR3) with detectable BCR/ABL transcript by a standard RQ-PCR assay for at least 12 months from the first documentation of the MMR;
    • Has been in MMR (i.e. MR3) but still has detectable BCR/ABL transcript by a standard RQ-PCR assay for at least 12 months from the first documentation of the MMR;
    • Up to two values above MMR (0.1%) are allowed in the last 12 months long as there was no change in the type or dose of TKI in last 6 months, none of the lab values were higher than CCR (1% or more) in the last 12 months, and all values in the last 6 months were at MMR or deeper;
    • Patient has not maintained MR4.5 (CMR) within the time of initiation of TKI therapy and pre-registration. Patient can have intermittent values of CMR (at or below MR4.5). However the patient has to have detectable disease (i.e. cannot be in CMR) in the last 2 assessments before pre-registration; AND 
    • Patient must have a diagnosis of chronic phase-CML has been confirmed by a bone marrow aspirate and/or biopsy with ≤ 10 % myeloid blasts (i.e., no accelerated or blast phase) within 21after consenting and pre -registration to step 0 and MMR status and BCR/ABL results meets the criteria outlined above.
      • NOTE: Please be aware of the required timeframe restrictions. Patients are required to enroll on Step 1 within 21 days from the date of consenting (step 0, pre-registration)
  • Patients with diagnoses of accelerated or blast phase CML are not eligible.
  • Patient has been on TKI therapy (first and/or second line) for at least 2 years (starting from when first TKI was initiated) prior to pre-registration:
    • Allowed TKIs include:
      • • Dasatinib: 50 – 180 mg per day;
      • • Imatinib: 200 – 800 mg per day;
      • • Nilotinib: 200 – 400 mg every 12-24 hours.
  • Patients must have been on a stable dose of the current TKI for the last 3 months prior to pre-registration. For patients with two values of above MMR (0.1%) within the last 12 months, patient must have been on stable dose of the current TKI for the last 6 months prior to pre-registration.
  • For patients who are on second line TKI, patient has been on second line TKI for at least a year from start date of second line TKI.
  • Patient must not have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Patients must not have received a prior allogeneic transplant.

REGISTRATION TO TREATMENT (STEP 1)

  • Institution has received central BCR-ABL test results confirming MRD positive status and bone marrow aspirate and/or biopsy has confirmed chronic phase CML (i.e. no accelerated or blast phase CML) Bone marrow showing morphologic remission is acceptable.
  • Patients have an ECOG Performance Status of 0-2.
  • Diagnosis of chronic phase-CML must had been confirmed by a bone marrow aspirate and/or biopsy with ≤ 10 % myeloid blasts (i.e., no accelerated or blast phase) within 21 days prior to registration to step 1. Bone marrow aspirate and/or biopsy showing morphologic remission is acceptable. MMR and BCR/ABL status meets the criteria defined above.
  • No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment. Patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation
  • No current use of corticosteroids from time of consent to registration.
    • EXCEPTION: Low doses of steroids (< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical condition (e.g., chronic adrenal insufficiency) is permitted.
  • No other active primary malignancy (other than non-melanomatous skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to ≤ 2 years.
    • NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy for their cancer).
  • Women must not be pregnant or breastfeeding due to the potential for congenital abnormalities and of harm to nursing infants due to the treatment regimens used. Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment
    • All females of childbearing potential must have a negative urine or serum pregnancy test conducted within 14 days prior to registration to rule out pregnancy. A urine or serum pregnancy test must be repeated within 72 hours prior to receiving the first dose of pembrolizumab if the test done for eligibility/registration to step 1 is done outside of this 72 hour window. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
    • A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point; 2)has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential)for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
    • Female of child bearing potential? ______ (Yes or No)
      • Date of urine/serum study: ___________
  • Women of childbearing potential and sexually active males must use accepted and effective method(s) of contraception or to abstain from sex from time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment. 
  • Patient may not be currently participating and receiving study therapy or have participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of registration.
  • Patient must not have a diagnosis of immunodeficiency or be receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment.
  • Patient must not have a known history of active TB (Bacillus Tuberculosis).
  • Patient must not have a history of hypersensitivity to pembrolizumab or any of its excipients.
  • Patient must not have received a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to registration or have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Patient must not have had prior chemotherapy, targeted small molecule therapy (aside from imatinib, dasatinib, or nilotinib), or radiation therapy within 2 weeks prior to registration to Step 1. Patients also must have recovered from all adverse events due to a previously administered agent.
    • NOTE: Patients with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
    • NOTE: Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease).
  • Patients who have received major surgery must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Patient must not have a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Patient must not have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of protocol treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to protocol treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Patient must not have active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Patient must not have known history of, or any evidence of active, non-infectious pneumonitis.
  • Patient must not have an active infection requiring systemic therapy.
  • Patient must not have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Patient must not have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Patients who are Human Immunodeficiency Virus (HIV) positive are eligible if they have undetectable HIV viral load and CD4+ T-cell count ≥ 250/mm^3.
  • Patients with a known positive test for Hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection may be be enrolled if the viral load by PCR is undetectable with/without active treatment.
  • Patients must not have a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive).
  • Patient must not have received a live vaccine within 30 days of registration.
    • NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
  • Patients must meet the following criteria with all screening labs performed within 14 days prior to registration:
    • Absolute neutrophil count (ANC) ≥ 1,500 /mcL
      • ANC: _________ Date of Test: _________
    • Platelet count ≥ 100,000 /mcL
      • Platelet:_______ Date of Test: _________
    • Hgb ≥ 9.0 g/dL OR ≥ 5.6 mmol/L without transfusion of EPO dependency
      • Hgb:__________ Date of Test:__________
    • Serum creatinine ≤ 1.5 X upper limit of normal (ULN) OR Creatinine clearance (per institutional standards) ≥ 60 mL/min for patient with creatinine levels > 1.5 X ULN
      • Serum creatinine ______________Date of Test: ________
    • or
      • Creatinine clearance: __________ Date of Test: ________
    • Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 X ULN
      • Bilirubin: __________ Institutional ULN: _________ Date of Test: __________
    • AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
      • ALT: _______ Institutional ULN: _________ Date of Test: _______
      • AST:_______  Institutional ULN:_________ Date of Test: _______
  • Patients should not be receiving concomitant strong CYP3A4 inducers or inhibitors ≤ 7 days prior to registration due to their potential to effect the activity or pharmacokinetics of study agents and/or QT interval prolongation toxicity. Should treatment with any of these agents be required, consult with study chair and reference Section 5.5 for TKI dose modifications related to concomitant drugs.
  • Patients who received prior allogeneic transplant are not eligible.

REGISTRATION TO TREATMENT (STEP 2)

  • Institution has received central BCR-ABL test results confirming MRD positive status at Cycle 16 or 17 or 18 following Step 1 treatment (MMR or deeper but not in CMR in the last two central lab checks before Step 2).
  • Patients have an ECOG Performance Status of 0-2.
  • No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment. Patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation.
  • No current use of corticosteroids. EXCEPTION: Low doses of steroids (< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical condition (e.g., chronic adrenal insufficiency) is permitted.
  • No other active primary malignancy (other than non-melanomatous skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to ≤ 2 years.
    • NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy for their cancer).
  • Patient must not have a diagnosis of immunodeficiency or be receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment.
  • Patient must not have a known history of active TB (Bacillus Tuberculosis).
  • Patient must not have a history of hypersensitivity to pembrolizumab or any of its excipients.
  • Women must not be pregnant or breastfeeding due to the potential for congenital abnormalities and of harm to nursing infants due to the treatment regimens used. Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment
  • All females of childbearing potential must have a negative urine or serum pregnancy within 14 days prior to registration on step 2 to rule out a pregnancy. A urine or serum pregnancy test must be repeated within 72 hours prior to receiving the first dose of pembrolizumab on step 2 if the test done for eligibility/registration to step 2 is done outside of this 72 hour window. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2)has not undergone a hysterectomy or bilateral oophorectomy; or3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Female of child bearing potential? ______ (Yes or No)
    • Date of urine/serum study: ___________
  • Women of childbearing potential and sexually active males must use accepted and effective method(s)of contraception or to abstain from sex from time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment. (Refer to Section 5.6.2 for detailed information on contraception requirements while on this study).
  • Patient must not have known history of, or any evidence of active, non-infectious pneumonitis.
  • Patient must not have an active infection requiring systemic therapy.
  • Patient must not have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Patients who are Human Immunodeficiency Virus (HIV) positive are eligible if they have undetectable HIV viral load and CD4+ T-cell count ≥ 250/mm^3.
  • Patient with a known positive test for Hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection might be enrolled if the viral load by PCR is undetectable with/without active treatment.
  • Patients must not have a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive).
  • Patient must not have received a live vaccine within 30 days of planned start of study therapy.
    • NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
  • Patients must meet the following criteria with all screening labs performed within 14 days prior to registration:
  • Absolute neutrophil count (ANC) ≥ 1,500 /mcL
    • ANC:__________ Date of Test:__________
  • Platelet count ≥ 100,000 /mcL
    • Platelet:__________ Date of Test:__________
  • Hgb ≥ 9.0 g/dL OR ≥ 5.6 mmol/L without transfusion of EPO dependency
    • Hgb:__________ Date of Test:__________
  • Serum creatinine ≤ 1.5 X upper limit of normal (ULN) OR Creatinine clearance (per institutional standards) ≥ 60 mL/min for patient with creatinine levels > 1.5 X ULN
    • Serum creatinine ______________Date of Test:________
  • or
    • Creatinine clearance:__________ Date of Test:_________
  • Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 X ULN
    • Bilirubin:__________ Institutional ULN:_________ Date of Test:__________
  • AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
    • ALT: _______ Institutional ULN:_________ Date of Test: _______
    • AST: _______ Institutional ULN:_________ Date of Test: _______
  • Patients should not be receiving concomitant strong CYP3A4 inducers or inhibitors ≤ 7 days prior to registration due to their potential to effect the activity or pharmacokinetics of study agents and/or QT interval prolongation toxicity. Should treatment with any of these agents be required, consult with study chair and reference Section 5.5 for TKI dose modifications related to concomitant drugs.
Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Cancer, Chronic myelogenous leukemia, Leukemia
4-Methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide, Biological therapy for cancer, Cancer treatment, Chronic myeloid leukemia, Dasatinib, Hematopoietic system, Imatinib, Medical Oncology, Pembrolizumab [USAN:INN], dasatinib, imatinib, nilotinib, pembrolizumab
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Mayo Clinic — Rochester, MN

TROV-054 A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Patients With a KRAS Mutation

A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second-Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation

Joleen Hubbard
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-100884-P01-RST
19-000578
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Inclusion Criteria:

  • Histologically confirmed metastatic and unresectable CRC.
  • Documentation of a KRAS mutation in exon 2, 3, or 4 in primary tumor or metastasis, assessed by a CLIA-certified laboratory. Patients with concomitant KRAS and BRAF-V600 mutations are excluded from this study. Patients with Microsatellite Instability High/Deficient Mismatch Repair (MSI-H/dMMR) are also ineligible for enrollment in this study.
  • FFPE tumor tissue must be available for submission to a central laboratory in order for a patient to be eligible. If no archival tissue biopsy is available the patient must have a biopsy obtained at screening. Refer to Section 6.2.4 for guidelines regarding provision of tumor tissue samples.
  • Age ≥ 18 years.
  • ECOG performance status of 0 or 1
  • Signed informed consent for participation in the study.
  • Subject is not receiving any other standard-of-care or experimental cancer therapy. Patients participating in non-interventional surveys or observational studies are allowed.
  • Has failed treatment or is intolerant of fluoropyrimidine and oxaliplatin with or without bevacizumab.
    • Patients must have had systemic therapy within 180 days of the screening visit, but can have no anti-cancer therapy within 28 days of the planned first day of treatment on study;
    • Patients must have received oxaliplatin based chemotherapy with or without bevacizumab (≥ 6 weeks in duration). Patients who received maintenance therapy with fluoropyrimidines are eligible with or without rechallenge with oxaliplatin in combination with fluoropyrimidines;
    • Patients who received oxaliplatin/fluoropyrimidine-based neoadjuvant or adjuvant therapy and have disease recurrence or progression > 6 months from their last dose of neoadjuvant or adjuvant treatment (or > 6 months from surgery if no adjuvant therapy was administered) will be required to have received fluoropyrimidine/ oxaliplatin-based therapy with or without bevacizumab as first-line treatment for metastatic disease;
    • Patients must not have received prior irinotecan;
    • For patients with rectal cancer, sequential neoadjuvant and adjuvant therapy will count as a single systemic regimen for advanced disease;
    • Patients who discontinued first-line therapy because of toxicity are eligible as long as progression occurred < 6 months after the last dose of first-line therapy.
  • FOLFIRI therapy is appropriate for the patient as determined by the Investigator.
  • For a woman of child-bearing potential (WOCBP) or a male with a female partner who is a WOCBP: Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days of the final dose of any study drug.
    • Adequate contraception is defined as follows:
    • Complete true abstinence;
    • Consistent and correct use of 1 of the following methods of birth control:
    • Male partner who is sterile prior to the female patient’s entry into the study and is the sole sexual partner for that female patient;
    • Implants of levonorgesterol;
    • Injectable progestogen;
    • Intrauterine device (IUD) with a documented failure rate of less than 1% per year;
    • Oral contraceptive pill (either combined or progesterone only);
    • Barrier method, for example: diaphragm with spermicide or condom with spermicide in combination with either implants of levonorgesterol or injectable progestogen.
  • WOCBP must have a negative serum or urine pregnancy test within 5 days prior to enrollment.
    • WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea > 12 consecutive months); or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an IUD or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child-bearing potential.
  • Imaging computed tomography (CT)/magnetic resonance imaging (MRI) of chest/abdomen/pelvis or other scans as necessary to document all sites of disease performed within 28 days prior to the first dose of onvansertib. Only patients with measurable disease as defined per RECIST v1.1 are eligible for enrollment. CT is the preferred imaging modality, but MRI is also accepted.
  • Signed informed consent to provide blood sample(s) for specific correlative assays.


Exclusion Criteria:

  • Concomitant KRAS and BRAF-V600 mutation or MSI-H/dMMR.
  • Anti-cancer chemotherapy or biologic therapy administered within 28 days prior to the first dose of study drug. The exception is a single dose of radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before randomization.
  • More than one prior chemotherapy regimen administered in the metastatic setting.
  • Major surgery within 6 weeks prior to enrollment.
  • Untreated or symptomatic brain metastasis.
  • Women who are pregnant or breastfeeding.
  • Gastrointestinal (GI) disorder(s) that, in the opinion of the Investigator, would significantly impede the absorption of an oral agent (e.g., intestinal occlusion, active Crohn’s disease, ulcerative colitis, extensive gastric and small intestine resection).
  • Unable or unwilling to swallow study drug.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure (CHF) Class II or higher according to the New York Heart Association (NYHA) Functional Classification, unstable angina pectoris, clinically significant cardiac arrhythmia (see bevacizumab cardiac exclusions below), significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
    • Known active infection with Human Immunodeficiency Virus (HIV), with measurable viral titer, and/or active infection with hepatitis B or C (patients who have had a hepatitis B virus (HBV) immunization are eligible);
    • Known active infection with SARS-CoV-2;
    • Clinically significant ascites or pleural effusions. 
  • nown hypersensitivity to 5-FU/leucovorin.
  • Known hypersensitivity to irinotecan.
  • Abnormal glucuronidation of bilirubin; known Gilbert’s syndrome.
  • Patients with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or prostate, or other solid tumors curatively treated with no evidence of disease for > 2 years.
  • Any active disease condition that would render the protocol treatment dangerous or impair the ability of the patient to receive study drug.
  • Any condition (e.g., psychological, geographical, etc.) that does not permit compliance with the protocol.
  • Treatment with any of the drugs at the time of study treatment initiation.
  • QT interval with Fridericia’s correction (QTcF) > 470 milliseconds (Vandenberk 2016). The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate ECGs. In the case of potentially correctible causes of QT prolongation that are readily corrected (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during Screening and that result may be used to determine eligibility.
  • Planned concomitant use of medications known to prolong the QT/QTc interval according to institutional guidelines.
  • Presence of risk factors for torsade de pointes, including family history of Long QT Syndrome or uncorrected hypokalemia.
  • The following are exclusion criteria for bevacizumab:
    • History of cardiac disease: CHF Class II or higher according to the NYHA; active coronary artery disease, myocardial infarction within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of patients who have been receiving therapy and are deemed by the Investigator to have stable/controlled disease;
    • Current uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management) and prior history of hypertensive crisis or hypertensive encephalopathy;
    • History of arterial thrombotic or embolic events (within 6 months prior to study entry);
    • Significant vascular disease (e.g., aortic aneurysm, aortic dissection, symptomatic peripheral vascular disease);
    • Evidence of bleeding diathesis or clinically significant coagulopathy;
    • Major surgical procedure (including open biopsy, significant traumatic injury, etc.) within 28 days, or anticipation of the need for major surgical procedure during the study, and minor surgical procedure (excluding placement of a vascular access device) within 7 days prior to study enrollment;
    • Proteinuria at Screening as demonstrated by urinalysis with proteinuria ≥ 2+ (patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible);
    • Abdominal fistula, GI perforation, peptic ulcer, or intra-abdominal abscess within the past 6 months;
    • Ongoing serious, non-healing wound, ulcer, or bone fracture;
    • Known hypersensitivity to any component of bevacizumab;
    • History of reversible posterior leukoencephalopathy syndrome (RPLS).
  • Use of strong CYP3A4 or UGT1A1 inhibitors or strong CYP3A4 inducers. Patients currently receiving these agents who are able to switch to alternate therapy are not excluded. Inhibitors should be stopped at least 1 week prior to the first dose of protocol therapy and inducers should be stopped at least 2 weeks prior to initiation of protocol therapy.

Eligibility last updated 2/2/22. Questions regarding updates should be directed to the study team contact.

 

Biologic/Vaccine, Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, FOLFIRI chemotherapy, Folinic acid-fluororuracil-oxaliplatin regimen
Cancer, Colon cancer, Rectal cancer
Bevacizumab, Cancer treatment, Chemotherapy, Digestive system, Fluorouracil [USAN:USP:INN:BAN:JAN], Genetic mutation, Irinotecan [INN:BAN], Leucovorin, Medical Oncology, NMS-P937, Secondary malignant neoplasm of colon and/or rectum, bevacizumab, fluorouracil, irinotecan, leucovorin
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Mayo Clinic — Rochester, MN

R1979-ONC-1625: An Open-label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti-CD20 X Anti-CD3 Bispecific Antibody, in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

An Open-label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti-CD20 X Anti-CD3 Bispecific Antibody, in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Jose Villasboas Bisneto
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100888-P01-RST
19-003173
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Inclusion Criteria:

  • Age 18 years or greater.

For the FL grade 1-3a cohort only:

  • Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the “Other B-NHL” cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).

Disease-specific cohorts:

Patients should, in the judgment of the investigator, require systemic therapy for lymphoma at the time of study enrollment and should be deemed not appropriate for any other approved therapy with established benefit for that indication.

  • FL grade 1-3a cohort: patients with FL grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent; patients must have failed combination lenalidomide and rituximab treatment where approved or deemed not appropriate to receive this treatment according to the investigator.

DLBCL cohort:

  • Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.
  • Patients with de novo DLBCL or DLBCL that is transformed from a lower grade neoplasm (e.g., FL or CLL) may be enrolled.
  • Patients with DLBCL transformation from prior CLL can only be enrolled in the absence of a leukemic CLL component.
  • For patients with transformed DLBCL, prior systemic therapies administered for the lower grade neoplasm will not be considered among the prior lines of therapy for the purpose of determining eligibility.

The following subtypes based on the WHO classification are eligible:

  • DLBCL not otherwise specified (NOS):
    • Germinal center B-cell type;
    • Activated B-cell type.

MCL after BTK inhibitor therapy cohort:

  • New enrollment is paused for any patient with MCL as of Global Amendment 3 until further risk mitigation measures are put in place for this patient population.

MZL cohort:

  • Ppatients with MZL that has relapsed or is refractory to at least 2 prior lines of systemic therapy.

The following subtypes based on the WHO classification are eligible:

  • Extranodal MZL of mucosa-associated lymphoid tissue (MALT lymphoma);
  • Nodal marginal zone lymphoma;
  • Splenic marginal zone lymphoma;
  • Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL) that has relapsed or is refractory to at least 2 prior lines of systemic therapy;
  • New enrollment is paused for any patient with MCL as of Global Amendment 3 until further risk mitigation measures are put in place for this patient population.

The following subtypes based on the WHO classification are eligible:

  • Primary mediastinal (thymic) large B-cell lymphoma;
  • T-cell/histiocyte-rich large B-cell lymphoma;
  • Epstein-Barr virus (EBV)+DLBCL, NOS;
  • Burkitt lymphoma;
  • Burkitt-like lymphoma with 11q aberration;
  • High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements;
  • High-grade B-cell lymphoma, NOS;
  • B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma;
  • Follicular lymphoma, grade 3b.
  • Patients with Waldenstrom macroglobulinemia (WM, lymphoplasmacytic lymphoma) are excluded.
  • Measurable disease on cross sectional imaging (defined as at least 1 bi-dimensionally measurable nodal lesion of ≥ 1.5 cm in the greatest transverse diameter (GTD) regardless of the short axis diameter) documented by diagnostic imaging (computed tomography [CT], or magnetic resonance imaging [MRI]).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 6.
  • Adequate bone marrow function as documented by:
    • Platelet count ≥ 50 x 10^9 /L. A patient may not have received platelet transfusion therapy within 7 days prior to first dose of odronextamab in order to meet the platelet eligibility criterion;
    • Hemoglobin ≥ 9.0 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9 /L. A patient may not have received granulocyte colony stimulating factor within 2 days prior to first dose of odronextamab in order to meet the ANC eligibility criterion.
  • Patients with bone marrow involvement or splenic sequestration should meet the following hematologic parameters:
    • Platelet count ≥ 25 x 10^9 /L. A patient may not have received platelet transfusion therapy within 3 days prior to first dose of odronextamab in order to meet the platelet eligibility criterion;
    • Hemoglobin ≥ 7.0 g/dL;
    • Absolute neutrophil count (ANC) ≥ 0.5 x 10^9 /L.
    • A patient may not have received granulocyte colony stimulating factor within 2 days prior to first dose of odronextamab in order to meet the ANC eligibility criterion.
  • Adequate hepatic function:
    • Total bilirubin ≤1.5 x upper limit of normal (ULN) (≤ 3 x ULN if attributed to lymphoma infiltration of liver);
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (5  ULN if attributed to lymphoma infiltration of liver);
    • Alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5 x ULN if attributed to lymphoma infiltration of liver).
  • NOTES: Irrespective of the presence of lymphoma infiltration of the liver, a patient with an AST < 2.5  ULN and/or ALT > 2.5 x ULN concurrent with a total bilirubin >1.5 x ULN will be excluded.
  • Patients with known Gilbert syndrome will be excluded if the total bilirubin value is > 4 x upper limit of normal (ULN) for the local general population.
  • Serum creatinine ≤ 1.5 x ULN, or calculated creatinine clearance by Cockcroft-Gault formula ≥ 5.0 mL/min.
  • NOTE: Patients with a calculated creatinine clearance < 50 mL/min may be considered for enrollment if a measured creatinine clearance (based on 24-hour urine collection or other reliable method) is ≥ 50 mL/min.
  • Willingness to undergo tumor biopsy at baseline. If an investigator has determined that a baseline tumor biopsy cannot be obtained safely, the sponsor may grant an exception to the requirement for biopsy only after discussion with and approval by the medical monitor.
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).
  • Willing and able to comply with clinic visits and study-related procedures.
  • Provide informed consent signed by study patient or legally acceptable representative.
  • Able to understand and complete study-related questionnaires


Exclusion Criteria:

  • Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
  • Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter.
  • History of allogeneic stem cell transplantation.
  • Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy.
  • Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug.
  • History of neurodegenerative condition or CNS movement disorder. Patients with a history seizure within 12 months prior to study enrollment are excluded.
  • Vaccination within 28 days prior to first study drug administration with a vector that has replicative potential.
  • Another malignancy except B-NHL in the past 5 years, with the exception of nonmelanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent.
  • Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study or put the patient at significant risk, including but not limited to significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) and/or significant pulmonary disease (e.g., obstructive pulmonary disease and history of symptomatic bronchospasm).
  • Cardiac ejection fraction < 40% by echocardiogram or multigated acquisition (MUGA) scan.
  • Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug.
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or other uncontrolled infection.
    • Patients with HIV who have controlled infection (undetectable viral load and CD4 count above 350 cells/microliter either spontaneously or on a stable antiviral regimen) are permitted;
    • Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA polymerase chain reaction [PCR] that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted;
    • Patients who are hepatitis C virus antibody positive (HCV Ab +) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.
  • History of severe allergic reaction attributed to compounds with a similar chemical or biologic composition as that of the study drug or excipient. A severe allergic reaction is defined for this purpose as that requiring hospitalization and/or treatment with epinephrine.
  • Known hypersensitivity to both allopurinol and rasburicase.
  • Member of the clinical site study team or his/her immediate family, unless prior approval granted by the sponsor.
  • Women of childbearing potential (WOCBP) with a positive serum β-hCG pregnancy test are ineligible for this study.
  • Patients who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
  • Pregnant or breastfeeding women.
  • Women of childbearing potential* or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose. Sperm donation is prohibited during the study and for 6 months after the last dose of study drug. Highly effective contraceptive measures include: a. stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening b. intrauterine device (IUD); intrauterine hormone-releasing system (IUS) c. bilateral tubal ligation
  • vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the study participant and that the partner has obtained medical assessment of surgical success for the procedure). e. and/or sexual abstinence† , ‡ .  Women of childbearing potential are defined as women who are fertile following menarche until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a post-menopausal state. The above definitions are according to Clinical Trial Facilitation Group (CTFG) guidance. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation. † Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. ‡ Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception. Female condom and male condom should not be used together.
  • Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy.
Biologic/Vaccine, Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Follicular lymphoma, Lymphoma, Non-Hodgkin's lymphoma
Cancer treatment, Follicular non-Hodgkin's lymphoma, Hematopoietic system, Medical Oncology, Odronextamab [USAN]
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A Phase I/II Study of Nivolumab Plus or Minus Ipilimumab in Combination With Multi-Fraction Stereotactic Radiosurgery for Recurrent High-Grade Radiation-Relapsed Meningioma

A Study of Nivolumab and Multi-fraction Stereotactic Radiosurgery with or without Ipilimumab in Treating Participants with Recurrent Grade II-III Meningioma

Sani Kizilbash
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-100897-P01-RST
19-000939
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Inclusion Criteria:
 

  • Patients must have histologically confirmed World Health Organization (WHO) grade II-III meningioma which has relapsed after prior radiation therapy with radiologically progressive or recurrent disease.
  • Patients must have measurable disease, defined as at least 1 lesion that can be accurately measured in at least one dimension as >= 1 cm on brain MRI but with the maximum dimension =< 5 cm OR gross tumor volume < 20 cm^3. All relapsed disease would need to be eligible to be treated with reirradiation.
  • Patients must have at least one prior surgery with available archival formalin-fixed paraffin-embedded (FFPE) tumor blocks of the initial or recurrent meningioma. If there are multiple tumor blocks from multiple surgeries, the most recent tumor block (and ideally of the relapsed tumor after initial radiation therapy) should be submitted. Annotation regarding whether the tumor block is before or after initial radiation therapy should be provided.
  • Prior initial radiation therapy may include external beam radiation or radiosurgery, or combination of both. However, the total dose of prior radiation exposure to the site of recurrent tumor (for consideration of re-irradiation) cannot be more than 70 Gy. The duration since the previous radiation exposure to the site of reirradiation need to be at least 6 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
    •Leukocytes >= 3,000/mcL.
  • Absolute neutrophil count >= 1,500/mcL.
  • Platelets >= 100,000/mcL.
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN.
  • Creatinine =< 1.5 x institutional ULN OR glomerular filtration rate (GFR) >= 30 mL/min/1.73 m^2 for patients with creatinine levels above 1.5 x institutional normal.
  • The effects of nivolumab and/or ipilimumab on the developing human fetus are unknown. For this reason and because radiation therapy is known to be teratogenic, women of childbearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP should use an adequate method to avoid pregnancy for 5 months after the last dose of investigational drug. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception.
  • Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.
  • WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days and men who are sexually active with WOCBP use contraception for 5 half-lives plus 100 days
    •Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.


Exclusion Criteria:
 

  • Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
  • Patients who have had radiation therapy (to the site of reirradiation) within 6 months prior to entering the study.
  • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1); however, alopecia, sensory neuropathy =< grade 2, or other =< grade 2 not constituting a safety risk based on the investigator's judgment are acceptable.
  • Patients who are receiving any other investigational agents.
  • Patients who have previous treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab and/or ipilimumab.
  • History of severe hypersensitivity reaction to any monoclonal antibody.
  • Current use of immunosuppressive medication (EXCEPT for the following: Intranasal, inhaled, topical steroids, or local steroid injection [e.g. intra-articular injection]; systemic corticosteroids at doses =< 4 mg/day of dexamethasone or equivalent; steroids as premedication for hypersensitivity reactions [e.g., computed tomography (CT) scan premedication]).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. However, patients with human immunodeficiency virus (HIV) on stable therapy with minimal viral loads and patients with hepatitis B and hepatitis C who have received treatment with minimal viral loads will be eligible.
  • Pregnant women are excluded from this study because radiation therapy is teratogenic and that the effects of nivolumab and/or ipilimumab on the developing human fetus are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nivolumab and/or ipilimumab, breastfeeding should be discontinued if the mother is treated with nivolumab and/or ipilimumab.
  • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
    •Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).
  • Prior organ transplantation including allogeneic stem cell transplantation. 
  • Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis, or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • Live vaccination within 4 weeks of the first dose of nivolumab and while on trial is prohibited except for administration of inactivated vaccines.
Biologic/Vaccine, Radiation, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer, Stereotactic radiosurgery of brain tissue
Brain tumor, Cancer, Meningioma, Recurrent cancer
Biological therapy for cancer, Brain stereotactic radiosurgery, Cancer treatment, Central nervous system, Ipilimumab, MDX-1106, Malignant tumor of meninges, Medical Oncology, Neoplasm of meninges, Nervous system, Radiation therapy, Stereotactic radiosurgery, ipilimumab, nivolumab
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Mayo Clinic — Rochester, MN

ASTX727-03: A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects With Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS) (MDS)

Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk Myelodysplastic Syndromes

Aref Al-Kali
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-100925-P01-RST
19-004619
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Inclusion Criteria:

  • Able to understand and comply with the study procedures, understand the risks involved in the study, and provide legally effective informed consent before the first study-specific procedure.
  • Men or women ≥ 18 years with IPSS low risk or Int-1 MDS (all subjects). Subjects must have had at least 1 of the following disease-related criteria during the 8 weeks before randomization:
    • Red blood cell (RBC) transfusion dependence, defined as 2 or more units of RBC transfusions*;
    • Hb of ≤ 9.0 g/dL in at least 2 blood counts prior to randomization or in 1 blood count if RBC transfusion was received;
    • ANC of < 0.5×10^9 /L in at least 2 blood counts prior to randomization;
    • Platelet counts of < 50×10^9 /L in at least 2 blood counts prior to randomization.

*RBC transfusion administered for Hb levels ≤ 9.0 g/dL are counted.

  • ECOG performance status of 0 to 2.
  • Adequate organ function defined as follows:
    • Hepatic: Total or direct bilirubin ≤ 2 × upper limit of normal (ULN); aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) ≤ 5 × ULN;
    • Renal: serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance or glomerular filtration rate ≥ 50 mL/min.
  • Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential must agree to practice a highly effective contraceptive measure of birth control (as described in the protocol) and must agree not to become pregnant for 6 months after completing treatment; men with female partners of child-bearing potential must agree to practice a highly effective contraceptive measure of birth control (as described in the protocol) and must agree not to father a child while receiving treatment with ASTX727 and for at least 3 months after completing treatment.


Exclusion Criteria:

  • Treatment with any investigational drug or therapy within 2 weeks before study treatment, or 5 half-lives, whichever is longer, before the first dose of study treatment, or ongoing clinically significant AEs from previous treatment.
  • Prior treatment with azacitidine, decitabine, or guadecitabine.
    Treatments for MDS, including erythropoietins, colony-stimulating factors (CSFs), thrombopoietins, chemotherapy, and immunosuppression including calcineurin inhibitors, glucocorticoids, etc., must be concluded 1 month prior to study treatment.
  • Diagnosis of chronic myelomonocytic leukemia (CMML).
  • Poor medical risk because of other conditions such as uncontrolled systemic diseases or active uncontrolled infections.
  • Known significant mental illness or other condition, such as active alcohol or other substance abuse or addiction, that in the opinion of the investigator predisposes the subject to high risk of noncompliance with the protocol.
  • Life-threatening illness, medical condition or organ system dysfunction, or other reasons including laboratory abnormalities, which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ASTX727, or compromise the integrity of the study outcomes.
  • Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, prostate cancer or breast cancer under control with hormone therapy, or other cancer from which the subject has been disease free for at least 1 year.
  • Known active infection with human immunodeficiency virus or hepatitis viruses.

Eligibility last updated 3/18/22. Questions regarding updates should be directed to the study team contact.

 

Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy
Cancer, Myelodysplastic syndromes
Cancer treatment, Cedazuridine, Chemotherapy, Decitabine, Hematopoietic system, Medical Oncology, Myelodysplastic syndrome (clinical), cedazuridine, cedazuridine / decitabine, decitabine
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Mayo Clinic — Rochester, MN

Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, Alone or in Combination With Other Agents, in HLA-A2 Participants With NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO) (GSK208467)

A Study to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors

Steven Robinson
All
12 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100947-P01-RST
19-008233
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Inclusion Criteria:

  • Capable of giving signed informed consent including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. For participants <18 years of age (or the legal minimum age in the relevant country) their legal guardian must give informed consent. Pediatric participants will be included in age-appropriate discussion in order to obtain assent.
  • Participant must be ≥ 10 years of age at the time of signing the informed consent. Participant scheduled to receive clinical drug product supply must also weigh ≥ 40 kg. For participant scheduled to receive commercial drug product supply and weighing < 40kg, the Investigator must also consult with the Medical Monitor prior to inclusion.
  • Participant has a diagnosis of synovial sarcoma or myxoid/round cell liposarcoma, confirmed by local histopathology and with evidence of translocation per below: – for synovial sarcoma, the presence of a translocation between SYT on the X chromosome and SSX1, SSX2 or, SSX4 on chromosome 18 (may be presented in the pathology report as t (X;18)) is required; – for myxoid/round cell liposarcoma, the presence of a translocation t (12;16)(q13;p11) or the variant translocation t (12;22)(q13;q12) is required.
  • Participant has high-risk locally advanced (i.e. deeply seated, high grade, positive margins, large [≥5 cm], or locally recurrent) synovial sarcoma or myxoid/round cell liposarcoma.
  • Participant with synovial sarcoma or myxoid/round cell liposarcoma who is:
    • Newly diagnosed, previously untreated; OR
    • Relapsed after surgery or radiotherapy for localized disease; OR
    • Relapsed 1 year after adjuvant/neoadjuvant therapy for localized disease.
  • Male or female. Contraception requirements will apply at the time of leukapharesis and treatment.A representative tumor tissue specimen (archived or fresh biopsy) with associated pathology report should be available to perform NY-ESO-1 antigen expression analysis, unless a recent NY-ESO-1 expression test result from the same designated central laboratory, following the same procedures, has already been performed under a separate GSK-sponsored protocol or under another substudy. 

All the Inclusion Criteria in 1-7 must apply again prior to leukapheresis. In addition, the following criteria must also apply:

  • Life expectancy ≥ 24 weeks.
  • Participant has advanced (metastatic or unresectable) synovial sarcoma or myxoid/round cell liposarcoma. Unresectable refers to a tumor lesion in which clear surgical excision margins cannot be obtained without leading to significant functional compromise.
  • Participant must be positive for HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 alleles by a validated test in a designated central lab prior to leukapheresis.
    • NOTE: An HLA test result from the same designated central laboratory, following the same procedures, and performed under a separate GSK-sponsored protocol or under another substudy is acceptable.
  • Participant’s tumor has been pathologically reviewed by a designated central laboratory with confirmed positive NY-ESO-1 expression defined as:
    • 30% of cells that are 2+ or 3+ by immunohistochemistry.
    • NOTE: A NY-ESO-1 expression test result from the same designated central laboratory, following the same procedures, and performed under a separate GSKsponsored protocol or under another substudy is acceptable.
  • Left ventricular ejection fraction ≥ 45% with no evidence of clinically significant pericardial effusion.
  • Performance status: for participants 60, or for participants < 16 and Lansky > 60, or for participants ≥ 16 and < 18 years of age, Karnofsky > 60, or for participants or for participants ≥ 18 years of age, Eastern Cooperative Oncology Group (ECOG) of 0-1.
  • Participant must have adequate organ function and blood cell counts, within 7 days prior to the day of leukapheresis procedure (or first day of lymphodepletion during Treatment fitness assessment), as indicated by the following laboratory values.
  • Hematological
  • Absolute Neutrophil count (ANC) ≥1.5 x10^9 /L (without granulocute coloty-stimulating support);
  • Absolute Lymphocyte count (ALC) ≥ 0.5 x 10^9 /L;
  • Hemoglobin ≥ 8 g/dL or ≥ 5.6 mmol/L.
  • Platelets ≥ 100 x10^9 /L (not achieved by transfusion).
  • Creatinine clearance ≥ 40 mL/min.
  • Participants who are ≥ 18 and < 65 years of age must be assessed either:
    • by 24-hour urine creatinine collection; OR
    • by using Serum Creatinine (Scr) via an estimated creatinine clearance calculated as below: Step 1: estimated glomerular filtration rate (GFR) to be obtained from the Chronic kidney disease Epidemiology Collaboration (CKD-EPI) formula [Levey, 2009]:
    • Estimated GFR (mL/min/1.73m^2 ) = 141 × min(Scr/κ, 1), α × max(Scr/κ, 1)-1.209 × 0.993Age × 1.018 [if female] × 1.159 [if black] where:
    • Scr is serum creatinine in mg/dL, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min(Scr/κ,1) indicates the minimum of Scr/κ or 1, max(Scr/κ,1) indicates the maximum of Scr/κ or 1, and Age is in years.
    • Step 2: correction factor to be applied per the American National Kidney Foundation in order to obtain the estimated creatine clearance in mL/min Estimated CrCl (mL/min) = Estimated GFR (mL/min/1.73 m^2 ) × BSA (m2 ) / 1.73 m^2.
  • Participants ≥ 65 years of age must have renal function measured either by 24-hour urine creatinine collection or by nuclear medicine EDTA GFR measurement, according to standard practice at the treating institution.  Participants <18 years of age must have renal function measured either by 24-hour urine creatinine collection or by nuclear medicine EDTA GFR measurement or by serum creatinine collection, according to standard practice at the treating institution.
  • Participants < 18 years of age must have GFR ≥ 70mL/min/1.73m^2 OR have a serum creatinine based on age/gender as follows:
    • Age Maximum serum creatinine (mg/dL) Male Female
    • Age 10 to < 13 years > 1.2
    • Age 13 to < 16 years > Male 1.5  | Female 1.4
    • Age 16 to < 18 years > Male 1.7 | Female 1.4
  • Hepatic
  • Total bilirubin
  • Participants with Gilbert’s Syndrome (only if direct bilirubin ≤ 35%) | ≤ 1.5 x ULN (isolated bilirubin ≤ 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
  • ALT ≤ 2.5 x ULN (or ≤ 5 x ULN if documented history of liver metastases)
  • Coagulation
  • International normalized ratio (INR) OR prothrombin time (PT)
  • Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants Nutritional status.
  • Albumin ≥ 3.5 g/dL
    • Participants may be transfused or receive growth factor treatment to meet minimum hematologic values up to 7 days prior to determining eligibility;
    • Adequate Organ Function will be reassessed for eligibility prior to lymphodepletion: if, upon consultation with the Medical Monitor, there is evidence from laboratory values that recovery from last anti-cancer treatment is underway, hematology labs may be considered acceptable and requirements waved to proceed with lymphodepletion.
  • Participant is fit for leukapheresis and has adequate venous access for the cell collection.
  • Male or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Male Participants: Male participants are eligible to participate if they agree to the following during the intervention period starting at the first dose of chemotherapy for at least 12 months after receiving the T-cell infusion, or 4 months after there is no evidence of persistence/ gene modified cells in the participant’s blood, whichever is longer. Refrain from donating sperm Plus, either: Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below:
    • Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant (as a condom may break or leak);
    • Agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person.
  • Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    • Is not a WOCBP; OR
    • Is a WOCBP who will agree to use a barrier method (male condom) and use a contraceptive method that is highly effective (with a failure rate of < 1% per year) during the intervention period and for at least 12 months after receiving the T-cell infusion, or 4 months after there is no evidence of persistence/ gene modified cells in the participant’s blood, whichever is longer.  WOCBP should also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
    • A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before any dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Female participants of childbearing potential (FCBP) must have a negative urine or serum pregnancy test.
  • Safety assessments will be reassessed again prior to lymphodepletion. Treatment fitness will be established in consultation with Medical Monitor.

In addition, the following criteria must also apply:

  • Participant has measurable disease according to RECIST v1.1.
  • Supportive radiotherapy has not affected > 25% of bone marrow.
  • A biopsy (excisional, incisional, or core) of non-target tumor tissue obtained within 90 days prior to initiating lymphodepleting chemotherapy is mandatory if cleanically feasible. This biopsy will be used as baseline for biomarker analyses. If it is not feasible to obtain a fresh biopsy, an archival tumor tissue (FFPE block) taken after completion of the participant’s last line of therapy, preferably within 90 days prior to initiating lymphodepleting chemotherapy, may be accepted at the discretion of the Medical Monitor (or designee). For participants who already provided a fresh biopsy for antigen expression and did not receive any supportive or intermediate anti-cancer therapy, the screening biopsy will be used for baseline.


Exclusion Criteria:

  • Participant has been previously treated for advanced (metastatic or unresectable) synovial sarcoma or myxoid/round cell liposarcoma.
  • Central nervous system (CNS) metastases.
  • Any other prior malignancy that is not in complete remission.
  • Exceptions include:
    • completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma (e.g., melanoma in situ, basal cell carcinoma, prostate cancer in-situ, periosteal osteosarcoma);
    • previous malignancies that have been definitively treated, and have been in remission for 5 years may be enrolled upon consultation with sponsor Medical Monitor or designee.
  • Previous treatment with genetically engineered NY-ESO-1 specific T cells.
  • Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody.
  • Prior gene therapy using an integrating vector.
  • Previous allogeneic hematopoietic stem cell transplant.
  • Clinically significant systemic illness: a. serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction, that in the judgment of the Investigator would compromise the participant’s ability to tolerate protocol therapy or significantly increase the risk of complications; OR
  • Prior or active demyelinating disease. Please note in particular that mandatory washout period restrictions must be respected before starting leukapheresis.

In addition, participants are not eligible for leukapharesis if any of the following criteria apply: 

  • Participant has history of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease (e.g., Crohn’s disease, systemic lupus) requiring steroids or other immunosuppressive treatments.
  • Uncontrolled intercurrent illness including, but not limited to:
    • Ongoing or active infection;
    • Clinically significant cardiac disease defined by congestive heart failure New York Heart Association (NYHA) Class 3 or Class 4;
    • Uncontrolled clinically significant arrhythmia;
    • Acute coronary syndrome (angina or myocardial infarction) in last 6 months;
    • Interstitial lung disease (participants with existing pneumonitis as a result of radiation are not excluded; however, participants cannot be oxygen dependent).
  • Current active liver or biliary disease (with the exception of Gilbert’s syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per Investigator assessment).
    • NOTE: Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, persistent jaundice or cirrhosis.
  • QTc > 480 msec.
    • NOTES: The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), and/or another method, machine-read or manually over-read. The specific formula that will be used to determine eligibility for an individual participant should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual participant and then the lowest QTc value used to include or discontinue the participant from the trial. For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used as specified in the Reporting and Analysis Plan (RAP).
  • Participant has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide, fludarabine, other agents used in the study.
  • Pregnant or breastfeeding females (due to risk to fetus or newborn).
  • Any prior treatment-related toxicities must be CTCAE (Version 5.0) ≤ Grade 1 at the time of initiating study intervention (except for non-clinically significant toxicities e.g., alopecia, vitiligo). Participants with Grade 2 toxicities that are deemed stable or irreversible (e.g., chemotherapy related arthritis or tendinitis, skin discoloration or erythema) can be enrolled.
  • Other standard of care lines of therapy are allowed only if guidelines and washout periods.
  • Investigational treatment within 30 days or 5 half-lives (whichever is shorter) prior to leukapheresis. Investigational vaccines (other than NY-ESO-1 vaccines that are not allowed) must follow the washout period. Exceptions to this rule must be evaluated by the Investigator in agreement with the Sponsor’s Medical Monitor (or designee).
  • Participant has active infection with HIV, HBV, HCV, EBV, CMV, syphilis, or HTLV as defined below:
    • Positive serology for HIV;
    • Active hepatitis B infection as demonstrated by test for hepatitis B surface antigen. Participants who are hepatitis B surface antigen negative but are hepatitis B core antibody positive must have undetectable hepatitis B DNA and receive prophylaxis against viral reactivation;
    • Active hepatitis C infection as demonstrated by hepatitis C RNA test. Participants who are HCV antibody positive will be screened for HCV RNA by any RT PCR or bDNA assay. If HCV antibody is positive, eligibility will be determined based on a negative Screening RNA value;
    • Positive test for syphilis (spirochete bacterium);
    • Positive serology for HTLV 1 or 2.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study. Treatment fitness will be established in consultation with Medical Monitor. Please note in particular that mandatory washout period restrictions must be respected before starting lymphodepletion.

In addition, participants cannot proceed with lymphodepletion or treatment if any of the following criteria apply:

  • Participant has received cytotoxic therapy within 3 weeks prior to lymphodepleting chemotherapy.
  • Systemic corticosteroids or any other immunosuppressive therapy within 2 weeks prior to lymphodepleting chemotherapy.
    • NOTE: Isolated doses of systemic corticosteroids are permitted to manage acute allergic reactions. Use of inhaled or topical steroids is not exclusionary.
  • Participant has received radiotherapy to the target lesions within 3 months prior to lymphodepletion. A lesion with unequivocal progression may be considered a target lesion regardless of time from last radiotherapy dose.
    • NOTE: There is no washout period for palliative radiation to non-target lesions.
  • Participant has received an anti-cancer vaccine within 2 months in the absence of tumor response. The participant should be excluded if their disease is responding to an experimental vaccine given within 6 months.
  • Participant has received live vaccine within 4 weeks prior to lymphodepletion or intends to receive live vaccine during the 3 month period following administration of GSK3377794.
  • Participant has received immune therapy (monoclonal antibody therapy, checkpoint inhibitors) within 4 weeks of lymphodepletion.
  • Participant had major surgery ≤ 28 days of first dose of study intervention.
Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer, Drug
Cancer, Sarcoma, Soft tissue sarcoma, Synovial sarcoma
Biological therapy for cancer, Cancer treatment, Cellular therapy, Medical Oncology, Metastatic sarcoma, Musculoskeletal system, NY-ESO-1, Synovial sarcoma
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Mayo Clinic — Rochester, MN

AGCT1532, Phase 3 Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours (AGCT1532 P3BEP)

Accelerated vs Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours

Carola Arndt
All
11 years to 45 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-100956-P01-RST
19-002993
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Inclusion Criteria:

  • Age ≥ 11 years and ≤ 45 years on the date of randomisation.
  • Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently.
  • Primary arising in testis, ovary, retro-peritoneum, or mediastinum.
  • Metastatic disease or non-testicular primary.
  • Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries)..
  • Adequate bone marrow function with ANC ≥1.0 x 10^9/L, Platelet count ≥100 x 10^9/L.
  • Adequate liver function where bilirubin must be ≤ 1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤ 2.0 x ULN; ALT and AST must be ≤ 2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be ≤ 5 x ULN.
  • Adequate renal function with estimated creatinine clearance of ≥ 60 ml/min according to the Cockcroft-Gault formula, unless calculated to be < 60 ml/min or borderline in which case GFR should be formally measured; e.g., with EDTA scan.
  • ECOG Performance Status of 0, 1, 2, or 3 10. Study treatment both planned and able to start within 14 days of randomisation. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments. Able to provide signed, written informed consent


Exclusion Criteria:

  • Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence).
  • Previous chemotherapy or radiotherapy, except:
    • pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin;
    • non-seminoma and poor prognosis by IGCCC criteria or stage IV malignant ovarian germ cell tumour in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (e.g., organ failure, vena cava obstruction, overwhelming burden of disease). Acceptable regimens include cisplatin 20 mg/m 2 days 1-2 and etoposide 100 mg/m 2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m 2 days 1-2; or baby-BOP.43 Patients must meet all other inclusion and exclusion criteria at the time of registration;
    • Participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation. Such patients must be discussed with the coordinating centre prior to registration, and must be registered within 10 days of commencing study chemotherapy.
  • Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin.
  • Significant co-morbid respiratory disease that contraindicates the use of bleomycin.
  • Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus.
  • Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety.
  • Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.
  • Known allergy or hypersensitivity to any of the study drugs.
  • Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.

Eligibility last updated 9/7/21. Questions regarding updates should be directed to the study team contact.

Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy
Cancer, Germ cell tumor
1,2-Diaminocyclohexaneplatinum II citrate, Bleomycin, Cancer treatment, Chemotherapy, Etoposide, Extragonadal teratoma, Malignant germ cell neoplasm of mediastinum, Malignant germ cell tumor of testis, Medical Oncology, Reproductive system, bleomycin, cisplatin, etoposide
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Mayo Clinic — Rochester, MN