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Avatar-Directed Chemotherapy in Platinum-Resistant Ovarian, Primary Peritoneal and Fallopian Tube Cancers

Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Saravut Weroha
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-106494-P01-RST
14-002986
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Inclusion Criteria:

  • Histologic confirmation of ovarian, primary peritoneal or fallopian tube cancer of any subtype
  • Prior consent to have tumors used for unspecified future research
  • Ability to provide written informed consent
  • Willing to agree to periodic contact with a member of the study team during the period that the cancer has not recurred and/or has not become platinum resistant
  • Willing to agree that the local medical oncologist may be informed that patient has agreed to participate in the study
  • Platinum resistant or refractory ovarian, primary peritoneal or fallopian tube cancer of any subtype; Note: platinum-sensitive disease is allowed in cases where there is a contraindication to platinum-based therapy (i.e., allergy to platinum); this must be reviewed and approved by the Principal Investigator
  • Successful Avatar engraftment with successful expansion and treatment outcome of Avatar therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status (ECOG performance status [PS]) of 0, 1 or 2
  • Measurable disease or non-measurable disease; for patients with non-measureable disease, they must also have a cancer antigen (CA)-125 measurement of > 35 U/mL or 2 X their documented nadir on 2 separate measurements 1 week apart
  • The following laboratory values obtained =< 21 days prior to registration; complete blood count (CBC), sodium, potassium, aspartate aminotransferase (AST), bilirubin and creatinine are to be obtained pre-study; Note: treatment initiation and dosing modification should be performed at the individual investigators discretion and be consistent with the product label and their medical practice
  • Negative urine or serum pregnancy test performed =< 7 days prior to registration, for women of child bearing potential only
  • Willing to return to enrolling institution for follow-up or have a local physician willing to submit response and outcome data; Note: any and all therapy, potentially in its entirety, may be conducted outside of the Mayo Clinic


Exclusion Criteria:

  • Any of the following:
    • Pregnant women
    • Nursing women
  • Prior treatment with Doxil, topotecan, Gemzar or Taxol chemotherapy for platinum-resistant cancer; Note: Allowed prior therapy with Doxil or Gemzar if given for platinum sensitive disease in combination with a platinum drug AND the Avatar data indicates a drug other than Doxil or Gemzar would be effective; Note: Allowed prior therapies for patients following confirmation of platinum-resistant cancer include:  
    • Therapeutic antibodies, such as bevacizumab
    • Small molecule kinase inhibitors, such as pazopanib
    • Vaccines and immunotherapy All of these exceptions should be confirmed with the Principal Investigator (PI) prior to registration
  • 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
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; Note: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
  • Uncontrolled intercurrent illness judged by the treating investigator to preclude treatment with chemotherapy
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Other active malignancy =< 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; Note: if there is a history of prior malignancy, they must not be receiving treatment for their cancer
Biologic/Vaccine, Drug, Other, Chemotherapy
Cancer, Fallopian tube cancer, Ovarian cancer, Peritoneal cancer
Chemotherapy, Malignant tumor of fallopian tube, Malignant tumor of ovary, Malignant tumor of peritoneum, Medical Oncology, Reproductive system, gemcitabine
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SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes

A Blanket Protocol to Study Oral Regorafenib in Patients with Selected Sarcoma Subtypes

Scott Okuno
All
5 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-106512-P01-RST
14-000401
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Inclusion Criteria:

  • Age ≥ 10 years for Liposarcoma, Osteosarcoma, and Ewing sarcoma; Age ≥ 5 years for Rhabdomyosarcoma cohorts
  • Weight ≥ 15 kg (33 lb)
  • Patients must have histologically or cytologically confirmed advanced/metastatic liposarcoma, osteogenic sarcoma, Ewing/Ewing-like sarcoma of soft tissue or bone, fusion-positive alveolar rhabdomyosarcoma or embryonal rhabdomyosarcoma/fusion-negative alveolar rhabdomyosarcoma
  • WHO Performance Status 0, 1 or 2. A maximum of 1/3 of patients in cohorts A & B may be WHO performance status 2
  • At least one prior line of systemic therapy for the sarcoma diagnosis (neoadjuvant, adjuvant or metastatic disease)
  • All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v 4.0 Grade 1 or less (except alopecia) at the time of signing the Informed Consent Form (ICF)
  • Subject must be able to swallow and retain oral medication
  • At least one site of measurable disease on x-ray/CT/MRI scan as defined by RECIST 1.1
  • Adequate organ function within 14 days of registration
  • Evidence of progression of disease as defined by RECIST 1.1 (i.e. new disease sites or 20% growth of index lesions) within 6 months of registration
  • Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS (central nervous system) metastatic disease and are without evidence of clinical progression for at least 12 weeks after therapy


Exclusion Criteria:

  • Patients with documentation of well differentiated liposarcoma only (of the well differentiated/dedifferentiated liposarcoma family) are specifically excluded, owing to its characteristically slow growth. If high grade areas are suspected (dedifferentiation), but not proved by pathology analysis (e.g. after primary resection of a well-differentiated liposarcoma), a biopsy must be performed to demonstrate the high-grade dedifferentiated disease
  • Prior systemic therapy with a small molecule oral kinase inhibitor, including but not limited to: pazopanib, sunitinib, sorafenib, everolimus, sirolimus, vemurafenib, dasatinib and trametinib
  • Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study. Patients who progress on placebo are specifically allowed to enroll on the treatment arm of the study if they meet all other entry criteria
  • Concurrent, clinically significant, active malignancies within 12 months of study enrollment
  • Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
  • Major surgery within 28 days prior to study registration or those patients who have not recovered adequately from prior surgery
  • Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvis bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy
  • Patients who have received prior systemic therapy < 14 days prior to study registration or have not recovered adequately from toxicities to CTCAE v. 4.03 grade 1 or less; prior investigational therapy may not have been given < 5 half-lives of last dose of treatment, or < 14 days, whichever is greater
  • Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v 4.0] on repeated measurement) despite optimal medical management
  • Active or clinically significant cardiac disease including: Congestive heart failure-New York Heart Association (NYHA) > class II, Active coronary artery disease, Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, Unstable angina (anginal symptoms at rest), new onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
  • Evidence or history of bleeding diathesis
  • Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to study registration
  • Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment
  • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
  • Ongoing infection > Grade 2 NCI-CTCAE v 4.03
  • Presence of a non-healing wound, non-healing ulcer, or benign bone fracture (patients with stress insufficiency fractures e.g. from osteoporosis or pathological fracture from tumor are eligible for study)
  • Patients with seizure disorder requiring medication
  • Proteinuria > 100 mg/dl on urine analysis
  • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
  • Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 4.03 Grade 2 dyspnea)
  • History of organ allograft (including corneal transplant).
  • Known or suspected allergy or hypersensitivity to regorafenib, or excipients of the formulations given during the course of this trial
  • Any malabsorption condition.
  • Women who are pregnant or breast-feeding.
  • Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
  • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
  • Inability to comply with protocol required procedures
  • Use of any herbal remedy (e.g. St. John wort [Hypericum perforatum])

Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Medication administration: oral
Bone cancer, Cancer, Ewing sarcoma, Liposarcoma, Osteosarcoma, Sarcoma, Soft tissue sarcoma
Cancer treatment, Chemotherapy, Ewing's sarcoma of bone, Liposarcoma, Medical Oncology, Musculoskeletal system, Osteosarcoma of bone, Regorafenib [USAN:INN], Targeted drug therapy, regorafenib
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MC1485, A Phase II Study of Anti-PD-1 Antibody (MK-3475) in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Other Low Grade B Cell Non-Hodgkin Lymphoma (NHL)

Pembrolizumab Alone or With Idelalisib or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Non-Hodgkin Lymphomas

Wei Ding
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-106534-P01-RST
14-005666
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Inclusion Criteria

CLL/SLL patients only

  • Diagnosis of CLL according to the National Cancer Institute (NCI) criteria or SLL according to the World Health Organization (WHO) criteria
  • This includes previous documentation of biopsy-proven small lymphocytic lymphoma or
  • Diagnosis of CLL according to NCI working group criteria as evidenced by all of the following:
    • Peripheral blood B cell count of > 5 x 10^9/L consisting of small to moderate size lymphocytes;
    • Immunophenotyping consistent with CLL defined as:
      • The predominant population of lymphocytes share both B-cell antigens;
      • Clonality as evidenced by kappa (κ) or lambda (λ) light chain expression  or other genetic method;
      • Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL;
      • Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative fluorescent in situ hybridization (FISH) analysis  on peripheral blood or tissue biopsy or negative immunohistochemical stains for cyclin D1 on involved tissue biopsy.
  • Patients must be previously treated with at least one prior line of therapy.
  • Prior chemotherapy or biologic novel therapy or anti-cancer monoclonal antibody based therapy for treatment of CLL will be considered prior therapy:
    • Nutraceutical treatments with no established benefit in CLL (such as epigallocatechin gallate or EGCG, found in green tea or other herbal treatments) will not be considered "prior treatment";
    • Prior oral corticosteroid therapy for an indication other than CLL will not be considered "prior treatment."
  • Previous use of corticosteroids in the combination with other therapy for treatment of autoimmune complications of CLL does constitute prior therapy for CLL.
  • Have progressive disease with any one of the following characteristics based on standard criteria for treatment as defined by the NCI-Working Group (WG) 1996.
  • Symptomatic CLL characterized by any one of the following:
    • Weight loss ≥ 10% within the previous 6 months;
    • Extreme fatigue attributed to CLL;
    • Fevers ≥ 100.5*F for 2 weeks without evidence of infection;
    • Drenching night sweats without evidence of infection.
  • Evidence of progressive bone marrow failure with hemoglobin ≤ 11 g/dL or platelet count ≤ 100 x 10^9/L.
  • Symptomatic or progressive lymphadenopathy, splenomegaly, or hepatomegaly:
    • Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not sufficient for protocol therapy.

Low Grade B-NHL patients only

  • Histologically confirmed relapsed (response to last treatment ≥ 6 months duration) or refractory (no response to last treatment or response duration < 6 months) indolent/low grade B cell NHL:
    • If patient has received previous anti-PD-1 or anti-PDL-1 consult with study chair.
  • Follicular lymphoma, grades 1, 2 and 3.
  • Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT) type.
  • Splenic and nodal marginal zone lymphoma.
  • Lymphoplasmacytic lymphoma including Waldenstrom macroglobulinemia.
  • Measurable disease (at least 1 lesion of ≥ 1.5 cm in diameter) as detected by computed tomography (CT) or the CT images of the positron emission tomography (PET)/CT:
    • Patients with Waldenstrom macroglobulinemia are not required to have measurable disease by CT or PET/CT if monoclonal protein is detectable by serum protein electrophoresis and/or immunoglobulin M (IgM) level is at least 2 times upper limit of normal.

All patients

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  • Creatinine ≤ 1.5 X upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN.
  • Platelet count ≥ 25 x 10^9/L.
  • Absolute neutrophil count ≥ 0.5 X 10^9/L.
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) unless due to Gilbert's disease:
    • If total bilirubin is > 1.5 x ULN, a direct bilirubin should be performed and must be ≤ upper limit of normal.
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 X ULN.
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
  • Provide informed written consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Willing to provide bone marrow and blood samples for correlative research purposes.
  • Must have failed or be unable to tolerate or refused other available Food and Drug Administration (FDA) approved effective therapies:
    • Patients should not have other treatment options considered curative.


Exclusion Criteria:

  • Currently participating in or has participated in a study of an investigational agent or using an investigational device ≤ 28 days prior to registration.
  • Receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy ≤ 7 days prior to registration.  Exceptions:
    • Low doses of steroids (≤ 20 mg of prednisone or equivalent dose of other steroid/day) used for treatment of non-hematologic medical conditions;
    • Previous use of corticosteroids is allowed;
    • After initiation of MK-3475 therapy, steroid can be used for management of potential immune mediated adverse events  for less than 8 weeks of therapy;
    • Topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption) are permitted.
  • Prior anti-cancer monoclonal antibody < 28 days prior to registration or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Prior chemotherapy or radiation therapy ≤ 14 days prior to registration or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent:
    • Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study;
    • If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Known additional malignancy that is progressing or requires active treatment.  Exceptions:
    • Richter's transformation or Hodgkin's transformation of the CLL are permitted;
    • In situ cervical cancer that has undergone or will undergo potentially curative therapy;
    • Basal cell carcinoma, squamous cell carcinoma, melanoma of the skin that has undergone or will undergo potentially curative therapy.
  • Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease/syndrome difficult to control in the past.  Exceptions:
    • Conditions not expected to recur in the absence of an external trigger are permitted to enroll;
    • Patients with psoriasis not requiring systemic treatment are permitted for participation;
    • Patients who have a positive Coombs test but no evidence of hemolysis are permitted for participation;
    • Subjects with hypothyroidism stable on hormone replacement, diabetes or Sjogren's syndrome are permitted for the study;
    • Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study;
    • Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule.
  • Evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Active infection requiring systemic therapy:
    • When the infection is controlled, patients are permitted for this study.
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Any of the following:
    • Pregnant women;
    • Nursing women;
    • Men or women of childbearing potential who are unwilling to employ adequate contraception starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Known to be human immunodeficiency virus (HIV) positive.
  • Known active hepatitis B or hepatitis C:
    • Patients with a positive hepatitis B core antibody but with negative hepatitis B DNA may participate, but must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician;
    • Intravenous immunoglobulin (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, but should have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician.
  • Received a live vaccine ≤ 30 days prior to registration.
  • New York Heart Association classification III or IV cardiovascular disease or recent myocardial infarction or unstable angina pectoris or cardiac arrhythmia (< 30 days).
  • Active central nervous system (CNS) lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells that requires therapy.
  • Has a clinically significant coagulopathy per investigator's assessment.
  • Has received an allogeneic stem cell transplant.
Biologic/Vaccine, Drug, 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 in relapse, Hematopoietic system, Ibrutinib [USAN:INN], Idelalisib [USAN:INN], Low grade B-cell lymphoma, Medical Oncology, Pembrolizumab [USAN:INN], Targeted drug therapy, ibrutinib, idelalisib, pembrolizumab
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ANBL1232, Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients With Non-high-risk Neuroblastoma

Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma

Wendy Allen-Rhoades
All
up to 17 months old
Phase 3
This study is NOT accepting healthy volunteers
0000-106574-P01-RST
14-005835
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Inclusion Criteria:

  • Patients must be:

    • < 12 months (< 365 days) of age at diagnosis with INRG stage L1; or
    • < 18 months (< 547 days) of age at diagnosis with INRG stage L2 or stage Ms neuroblastoma/ganglioneuroblastoma
  • Enrollment on ANBL00B1 is required for all newly diagnosed patients
  • Patients must have newly diagnosed v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) non-amplified neuroblastoma (International Classification of Diseases for Oncology [ICD-O] morphology 9500/3) or MYCN non-amplified ganglioneuroblastoma verified by histology
  • Patients must meet the specified criteria for one of the treatment groups defined below; genomic features include MYCN gene amplification, segmental chromosome aberrations (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) and deoxyribonucleic acid (DNA) index

    • "Favorable" genomic features are defined by one or more whole-chromosome gains or hyperdiploid tumor (DNA index > 1) in the absence of segmental chromosome aberrations as defined above
    • "Unfavorable" genomic features are defined by the presence of any segmental chromosome aberration (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) or diploid tumor (DNA index = 1); this includes copy neutral loss of heterozygosity (LOH)
    • Only patients with MYCN non-amplified tumors are eligible for this study
  • Group A: patients < 12 months (< 365 days) of age with newly diagnosed INRG stage L1 neuroblastoma/ganglioneuroblastoma who meet the following criteria:

    • Greatest tumor diameter < 5 cm of adrenal or non-adrenal origin
    • Patients with non-adrenal primaries are eligible, but must have positive uptake on metaiodobenzylguanidine (MIBG) scan or elevated catecholamine metabolites (urine or serum) to support the diagnosis of neuroblastoma
    • No prior tumor resection or biopsy
  • Group A will be further split into two subsets, which are mutually exclusive, for statistical purposes

    • Group A1:

      • > 6 months and < 12 months of age with an adrenal primary tumor < 5 cm in greatest diameter OR
      • Patients less than 6 months of age with an adrenal primary tumor > 3.1 and < 5 cm in greatest diameter OR
      • < 12 months of age with a non-adrenal primary site < 5 cm in greatest diameter
    • Group A2: =< 6 months of age with an adrenal primary site and tumor =< 3.1 cm in greatest diameter.
  • Group B: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage L2 neuroblastoma/ganglioneuroblastoma who meet the following criteria:

    • No life threatening symptoms or no impending neurologic or other organ function compromise (e.g. epidural or intraspinal tumors with existing or impending neurologic impairment, periorbital or calvarial-based lesions with existing or impending cranial nerve impairment, anatomic or mechanical compromise of critical organ function by tumor [abdominal compartment syndrome, urinary obstruction, etc.])
    • No prior tumor resection, tumor biopsy ONLY
    • Only patients with both favorable histology and favorable genomic features will remain on study as part of Group B; the institution will be notified of histologic and genomic results within 3 weeks of specimen submission on ANBL00B1
  • Group C: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage Ms neuroblastoma/ganglioneuroblastoma
  • No prior radiotherapy or chemotherapy, with the exception of dexamethasone, which is allowed
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met


Exclusion Criteria:

  • Patients with MYCN amplified tumors
  • Group B and C patients who do not enroll on ANBL1232 within 4 weeks of definitive diagnostic procedure
  • Group A and C patients, not required to undergo tumor biopsy, who do not enroll on ANBL1232 within 4 weeks of confirmatory imaging study
Drug, Other, Chemotherapy, Drug therapy
Cancer, Neuroblastoma, Tumors and masses
Chemotherapy, Medical Oncology, Nervous system, Neuroblastoma
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Tagraxofusp (SL-401) in Patients with Chronic Myelomonocytic Leukemia (CMML)

SL-401 in Advanced, High Risk Myeloproliferative Neoplasms (Systemic Mastocytosis, Advanced Symptomatic Hypereosinoophic Disorder, Chronic Myelomonocytic Leukemia)

Mrinal Patnaik
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-106593-P01-RST
14-008096
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Inclusion Criteria:

All Patients (Stages 2 and 3A):

1.            The patient is ≥18 years old.       

2.            The patient has a life expectancy of >6 months.               

3.            The patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.             

4.            The patient has adequate baseline organ function, including cardiac, renal, and hepatic function:

•             Left ventricular ejection fraction (LVEF) ≥ institutional lower limit of normal as measured by multigated acquisition scan (MUGA) or 2-dimensional (2-D) echocardiogram (ECHO) within 28 days prior to start of therapy and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG).

•             Serum creatinine ≤1.5 mg/dL.

•             Serum albumin ≥3.2 g/dL (or ≥32 g/L) in the absence of receipt of IV albumin within the previous 72 hours.

•             Bilirubin ≤1.5 mg/dL.

•             Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN).

•             Creatine phosphokinase (CPK) ≤2.5 times the ULN.

•             Absolute neutrophil count (ANC) ≥0.5 x 109/L.  

5.            If a woman of child-bearing potential (WOCBP), the patient has a negative serum or urine pregnancy test within 1 week prior to tagraxofusp treatment (intervals shorter than 1 week are acceptable, if required by institutional guidelines).       

6.            The patient (either male or female) agrees to use acceptable contraceptive methods for the duration of time in the study, and to continue to use acceptable contraceptive methods for 1 week after the last tagraxofusp infusion.                

7.            The patient has signed informed consent prior to initiation of any study-specific procedures or treatment.          

8.            The patient is able to adhere to the study visit schedule and other protocol requirements, including follow-up for response assessments.                

 Additional Abbreviated Inclusion Criteria Specific to Patients with MF (Stage 2):

1.            Patient meets the 2016 WHO diagnostic criteria for MF and has an IPSS/DIPSS/DIPSS-plus intermediate-2 or high-risk disease. Patients with IPSS/DIPSS/DIPSS-plus low or intermediate-1 risk disease who have at least one of the following symptoms are also eligible: MF-related anemia (Hb <10 g/dL), splenomegaly (palpable size >10 cm), leukocytosis (WBC >25 x 109/L), marked thrombocytosis (platelet count >1000 x 109/L), or constitutional symptoms (weight loss >10%, during prior 6 months or fever [>37.5°C or drenching night sweats for >6 weeks]), as recommended by the ELN/IWG 2018 criteria (Barbui 2018).         

2.            Patient is approved JAK therapy (JAK1/JAK2 or JAK 2) resistant/refractory or intolerant, in accordance with the ELN/IWG 2018 criteria (Barbui 2018), and at least 4 weeks have elapsed between the last dose of any MF-directed drug treatments, excluding HU, and study enrollment (first dose). HU can be continued until 2 weeks prior to study enrollment.       

3.            Patient is not eligible for an immediate allogeneic stem cell transplantation (SCT).

Additional Abbreviated Inclusion Criteria Specific to Patients with CMML (Stage 3A):

1.            Patient has a 2016 WHO-defined diagnosis of CMML (persistent monocytosis ≥1x109/L for at least 3 months, with other causes excluded, and monocytes ≥10% of WBC in peripheral blood, no criteria and no previous history of CML, ET, PV, and acute promyelocytic leukemia; if eosinophilic, neither PDGFRA, PDGFRB, FGFR1 rearrangements nor PCM1-JAK2 translocation; <20% blasts in peripheral blood and bone marrow aspirate; >1 following criteria: dysplasia in >1 myeloid lineage, acquired clonal cytogenetic or molecular abnormality in hematopoietic cells).    

2.            Patient has 2016 WHO-defined CMML-1 (2-4% blasts in peripheral blood and/or 5-9% blasts in bone marrow) and CMML-2 (5-19% blasts in peripheral blood and/or 10-19% blasts in bone marrow, and/or presence of Auer rods) (Arber 2016).    

3.            Patient is refractory/resistant/intolerant, as defined for the purposes of this study (in the absence of a standard definition for CMML) below, to HMAs, or HU, or intensive chemotherapy, including:

•             Resistance/intolerance to HU is defined as:

o             Uncontrolled myeloproliferation, (platelets >400x109/L and WBC >10x109/L after 3 months of at least 2 g/day of HU); or

o             Myelosuppression at a clinically relevant dose; or

o             Presence of unacceptable HU-related non-hematological toxicities, such as mucocutaneous manifestations, gastrointestinal symptoms, pneumonitis or fever at any dose of HU.

Conventional definition for HMA failure is defined for the purposes of this study (in the absence of a standard definition for CMML) as:

o             Disease progression following at least 4 to 6 cycles of 5-azacitidine or decitabine; or

o             Relapse after achieving response; or

o             Intolerance to 5-azacitidine or decitabine at the prescribed dose.

OR

•             Patient is classified as high-risk based on the presence of morphological features, as described by the 2016 WHO prognostic system (Arber 2016), and the clinical and molecular features described in molecularly-integrated prognostic systems, such as the Groupe Français des Myélodysplasies (GFM), Mayo Molecular Model (MMM), and the CMML specific prognostic model (CPSS-Mol) (Woo 2020), and thus is not expected to benefit from HMAs.  

4.            Patient is ineligible for an immediate allogeneic stem cell transplantation (SCT).


Exclusion Criteria:

All Patients (Stages 2 and 3A):

1.            Patient has persistent clinically significant toxicities Grade ≥2 from previous therapies, including cytotoxic chemotherapy, targeted therapies, biological therapies, or immunotherapies, not readily controlled by supportive measures (excluding alopecia, nausea, and fatigue).      

2.            Patient has received treatment with any disease-related therapy, including radiation therapy within 14 days of study entry.      

3.            Patient has received an allo-SCT within 3 months of study entry.              

4.            Patient has received treatment with another investigational agent within 14 days of study entry or concurrent treatment with another investigational agent.  

5.            Patient has previously received treatment with tagraxofusp or has a known hypersensitivity to any components of the drug product.           

6.            Patient has an active malignancy and/or cancer history (excluding myeloproliferative disorders and concomitant myeloid malignancies as specified in the inclusion criteria) that can confound the assessment of the study endpoints. Patients with a past cancer history (within 2 years of entry) and/or ongoing active malignancy or substantial potential for recurrence must be discussed with the Sponsor before study entry. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including superficial bladder cancer), cervical intraepithelial neoplasia, or organ-confined prostate cancer with no evidence of progressive disease.      

7.            Patient has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).     

8.            Patient has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that, in the Investigator’s opinion, would put the patient at significant risk for pulmonary complications during the study.

9.            Patient has known active or suspected disease involvement of the central nervous system (CNS). If suspected due to clinical findings, CNS disease should be ruled out with relevant imaging and/or examination of cerebrospinal fluid.     

10.          Patient is receiving immunosuppressive therapy, with the exception of corticosteroids as specified in the inclusion criteria and tacrolimus, for treatment or prophylaxis of graft-versus-host disease (GVHD). If the patient has been on immunosuppressive treatment or prophylaxis for GVHD, the treatment(s) must have been discontinued at least 14 days prior to study drug and there must be no evidence of Grade ≥2 GVHD. 

11.          Patient has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness that would limit compliance with study requirements.     

12.          Patient is pregnant or breast feeding.   

13.          Patient has known human immunodeficiency virus (HIV).            

14.          Patient has evidence of active or chronic Hepatitis B or Hepatitis C infection.      

15.          Patient is oxygen-dependent.  

16.          Patient has any medical condition that in the Investigator’s opinion places the patient at an unacceptably high risk for toxicities.     

Additional Exclusion Criteria Specific to Patients with MF (Stage 2) apply.

1.            Patient has a platelet count <20x109/L and either a history of a recent or active bleed or known acquired von Willebrand disease.       

2.            Patient fulfills the 2016 WHO criteria defining leukemic transformation of MF (presence of peripheral blood or bone marrow blast count >20%).         

3.            Patient received splenic irradiation within 28 days prior to study entry.  

Additional Exclusion Criteria Specific to Patients with CMML (Stage 3A) apply.

1.            Patient requires corticosteroid therapy at a dose of >20 mg daily >7 days or has had changes to their steroid regimen within 28 days of screening.     

2.            Patient has 2016 WHO-defined transformation to leukemia.       

3.            Patient has AML M4 (French-American-British subtype; myelomonocytic). (NB if this is suspected, the NPM1 gene must be assessed to determine eligibility.)         

Drug
Cancer, Leukemia, Myelofibrosis, Systemic mastocytosis
Hematopoietic system, Medical Oncology
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Mayo Clinic — Rochester, MN

E4512, A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Crizotinib in Treating Patients with Stage IB-IIIA Non-small Cell Lung Cancer that has been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

Aaron Mansfield
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-106601-P01-RST
14-007045
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Inclusion Criteria:

  • Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II, or non-squamous IIIA NSCLC per American Joint Committee on Cancer (AJCC) 7th edition and have had negative margins; N3 disease is not allowed
  • Baseline chest computed tomography (CT) with or without contrast must be performed within 6 months (180 days) prior to randomization to ensure no evidence of disease; if clinically indicated additional imaging studies must be performed to rule out metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
  • Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in echinoderm microtubule associated protein like 4 [EML4]-ALK fusion) as determined by the Vysis Break Point fluorescence in situ hybridization (FISH) assay and defined by an increase in the distance between 5' and 3' ALK probes or the loss of the 5' probe; this must have been performed:
    • By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory: report must indicate the results as well as the CLIA number of the laboratory which performed the assay; tissue must be available for submission for central, retrospective confirmation of the ALK fusion status via ALCHEMIST-SCREEN (ALLIANCE A151216) OR
    • Patient registered to and the ALK fusion status performed centrally on the ALCHEMIST-SCREEN (ALLIANCE A151216)
  • Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood or urine pregnancy test within 72 hours prior to randomization to rule out pregnancy; 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 not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Women of childbearing potential and sexually active males must be strongly advised to practice abstinence or use an accepted and effective method of contraception
  • Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • No known interstitial fibrosis or interstitial lung disease
  • No prior treatment with crizotinib or another ALK inhibitor
  • No ongoing cardiac dysrhythmias of grade >= 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, uncontrolled atrial fibrillation (any grade), or corrected QT (QTc) interval > 470 msec
  • No use of medications, herbals, or foods that are known potent cytochrome P450, subfamily 3A, polypeptide 4 (CYP3A4) inhibitors or inducers, included but not limited to those outlined
  • Patients must be adequately recovered from surgery at the time of randomization
  • The minimum time requirement between date of surgery and randomization must be at least 4 weeks (28 days)
  • The maximum time requirement between surgery and randomization must be:
    • 3 months (90 days) if no adjuvant chemotherapy was administered
    • 8 months (240 days) if adjuvant chemotherapy was administered
    • 10 months (300 days) if adjuvant chemotherapy and radiation therapy were administered
  • Patients must have completed any prior adjuvant chemotherapy or radiation therapy 2 or more weeks (6 or more weeks for mitomycin and nitrosoureas) prior to randomization and be adequately recovered at the time of randomization
    • NOTE: Patients taking low dose methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study
    • NOTE: Neo-adjuvant chemotherapy or radiation therapy for the resected lung cancer is not permitted
  • Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
  • Total serum bilirubin =< 1.5 x ULN
  • Absolute neutrophil count (ANC) >= 1500/mm^3
  • Platelets >= 30,000/mm^3
  • Hemoglobin >= 8.0 g/dL
  • Serum creatinine =< 2 x ULN
  • Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy, or radiation must have recovered to grade =< 1 with the exception of alopecia and the criteria outlined
  • Patients must not have any history of cancer within 5 years from randomization, with the exception of in-situ carcinomas and non-melanoma skin cancer
  • Patients may not be receiving any other investigational agents while on study
Drug, Other
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RU051417I - Phase I/II, Open-Label Study of R-ICE (Rituximab-Ifosfamide-Carboplatin-Etoposide) with Lenalidomide-R-ICE (R2-ICE) in Patients with First-Relapse/Primary Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

A Study of R-ICE and Lenalidomide for Treating Patients with First-Relapse/Primary Refractory Diffuse Large B-Cell Lymphoma

Grzegorz Nowakowski
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-106789-P01-RST
16-000179
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Inclusion Criteria

  • Phase I: Histological confirmation of expressing CD20 antigen as determined by pathology at the respective institution and central pathology review at Mayo Clinic Rochester. All types of B-cell lymphomas are allowed to participate. Patients with primary mediastinal large B-cell (PMLBCL) or transformed lymphoma are allowed to participate                                                                 
  • Phase II: Histological confirmation of  DLBCL expressing CD20 antigen as determined by pathology at the respective institution and central pathology review at Mayo Clinic Rochester.  Only Diffuse large B cell lymphoma patients are allowed to participate in Phase II. Patients with primary mediastinal large B-cell (PMLBCL) lymphoma or transformed lymphoma are not allowed to participate
  • Notes regarding slide submission
    • Central pathology review is mandatory but is retrospective in nature
    • Slides should be submitted within 30 days of enrollment
    • Patients can be enrolled prior to submission of slides
  • Has measurable disease (at least 1 lesion ≥ 1.5 cm in diameter) as detected by PET/CT
  • Only 1 line of previous anti-lymphoma therapy is allowed and not currently receiving any other agent that would be considered as a treatment for the lymphoma
  • Patients must be ≥ 2 weeks from prior anti-lymphoma therapy
  • The use of steroids and/or rituximab up to 1 week prior to registration for management of symptoms is allowed
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
  • Absolute neutrophil count (ANC) ≥ 1500/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Total bilirubin ≤ 2 × upper limit of normal (ULN) (unless related to lymphoma or Gilbert's disease) 
    • ≤ 5 × ULN for subjects with documented or suspected Gilbert's disease, or related to involvement of the liver by the lymphoma
  • Aspartate transaminase (AST) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 x ULN unless evidence of the direct liver and/or bone involvement by lymphoma, then ≤ 5 x ULN
  • Phase I subjects must have calculated creatinine clearance ≥ 60 ml/min by Cockcroft-Gault formula
  • Phase II subjects must have calculated creatinine clearance ≥ 30 ml/min by Cockcroft-Gault formula
  • Negative pregnancy test done ≤10-14 days before registrationdays prior to registration, for women of childbearing potential only
  • Provide informed written consent
  • Willing to return to enrolling institution for follow-up during the active monitoring phase of the study, i.e. active treatment and observation
  • Willing to provide blood samples for correlative research purposes
  • Considered transplant-eligible, as determined by the opinion of the investigator at the participating institution
    • The participating institution does not need to be a transplant center but patients can be referred to a transplant center if needed
  • Willing and able to register into and comply with the mandatory requirements of Celgene's REVLIMID (lenalidomide) Risk Evaluation and Mitigation Strategies (REMS™) program
  • Females of reproductive potential are willing and able to adhere to the scheduled pregnancy testing as required by Celgene's REVLIMID REMS™ program
  • Willing and able to take aspirin (81 mg) daily as prophylactic anticoagulation
    • Patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin

Exclusion Criteria

  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
    • Men must agree to use a latex condom during sexual contact with a female of child-bearing potential even if they have had a successful vasectomy
    • Women of child bearing potential must agree to use 2 methods of reliable contraception simultaneously
    • All patients must be counseled at a minimum of every 21 days about pregnancy precautions and risks of fetal exposure
  • Has any 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 including, but not limited to
    • Ongoing or active infection
    • Symptomatic congestive heart failur
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
    • Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
    • Patients with HIV on antiretroviral therapy other than zidovudine (AZT) and/or stavudine and without prior acquired immunodeficiency syndrome (AIDS) defining conditions and adequate CD4 count > 400 are eligible
  • History of myocardial infarction ≤ 180 days prior to registration
  • Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
    • Patients must be ≥ 2 weeks from prior anti-lymphoma therapy
    • The use of steroids and/or rituximab up to 1 week prior to registration for management of symptoms is allowed
  • Other active malignancy ≤ 3 years prior to registration, except for
    • Non-melanotic skin cancer
    • Carcinoma-in-situ of the cervix
    • Any cancer that, in the judgment of the investigator, has been treated with curative intent and will not interfere with the study treatment plan and response assessment
      • If there is a history of prior malignancy, they must not be receiving other specific treatment such as radiation, chemotherapy, or immunotherapy for their cancer
  • Unable or unwilling to take any prophylaxis
    • Patients with history of or new/active deep vein thrombosis/embolism/thrombophilia are allowed to participate if they are on appropriate therapeutic anticoagulation during the treatment on the trial
    • These patients would not need the aspirin with the lenalidomide unless clinically indicated
    • Patients must be able and willing to receive anticoagulation prophylactically versus therapeutically as clinically indicated
  • No history of radiation therapy to ≥ 25% of the bone marrow for other diseases
  • Receiving erythroid stimulating agents (epoetin alfa [EPO]: Procrit, Aranesp)
  • Has active or prior central nervous system (CNS) lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells
    • These patients are usually treated with CNS directed therapy
    • Screening for cerebrospinal fluid CNS involvement is NOT required but can be performed per treating medical doctor  discretion
  • Active hepatitis B as defined by seropositivity for hepatitis B surface antigen (HBsAg)
    • Subjects with positive hepatitis B core antibody titers and normal liver transaminases are allowed provided that antiviral prophylaxis is administered per institutional guidelines
    • Subjects with hepatitis C antibody will be eligible provided that they do not have elevated liver transaminases or other evidence of active hepatitis
Biologic/Vaccine, Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, R-ICE chemotherapy regimen
Cancer, Diffuse large b-cell lymphoma, Lymphoma, Non-Hodgkin's lymphoma
Cancer treatment, Carboplatin, Chemotherapy, Diffuse non-Hodgkin's lymphoma, large cell (clinical), Etoposide, Hematopoietic system, Ifosfamide, Lenalidomide, Medical Oncology, Rituximab, Targeted drug therapy, carboplatin, etoposide, ifosfamide, lenalidomide, rituximab
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CV185155, A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Venous Thromboembolism Prevention Versus No Systemic Anticoagulant Prophylaxis During Induction Chemotherapy in Children With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (T or B Cell) Treated With Asparaginase (CV185155)

A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase

Mira Kohorst
All
1 years to 17 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-106814-P01-RST
15-001971
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Inclusion Criteria:

  • New diagnosis of de novo ALL, lymphomas (T or B cell), or mixed-phenotype acute leukemia.
  • Planned 3-4 drug systemic induction chemotherapy with a corticosteroid, vincristine and a single dose or multiple doses of asparaginase, with or without daunorubicin.
  • Functioning Central Venous Access Device.
  • Must be able to tolerate oral medication or have it administered via an Nasogastric tube (NGT) or GT tube.
  • Males and females, age 1 year(365 days) to < 18 (17 years and 364 days) years.


Exclusion Criteria:

  • Subjects scheduled to have > 3 Lumbar Punctures over the course of the study treatment period.
  • Prior history of documented DVT or PE in the past 3 months.
  • Known inherited bleeding disorder or coagulopathy.
  • Major surgery [excluding Central Venous Access Device (CVAD) replacement and bone marrow aspiration and non-open biopsy] within the last 7 days prior to enrollment that may be associated with a risk of bleeding. Open biopsy is considered a major surgery.
  • Uncontrolled severe hypertension at enrollment. Severe hypertension is defined as a systolic or diastolic blood pressure (BP) > 5 mm Hg above the 95th percentile as defined by the National High Blood Pressure Education Program Working Group (NHBPEP) established guidelines for the definition of normal and elevated blood pressure in children.
  • Extreme hyperleukocytosis, white blood cell (WBC) counts over 200 x 10^9/L (200,000/microL) at the time of enrollment.
  • Liver dysfunction manifested by SGTP (ALT) > 5 X Upper limit of normal (ULN) and/or Aspartate aminotransferase (AST) >5 X ULN and/or direct (conjugated) bilirubin > 2 X ULN.
  • Renal function < 30% of normal for age and size as determined by the Schwartz formula
  • International normalized ratio (INR) > 1.4 and activated partial thromboplastin time (aPTT) > 3 seconds above the upper limit of normal for age, within 1 week prior to enrollment.
  • History of allergy to apixaban or Factor Xa inhibitors.
  • History of significant adverse reaction or major bleeding related adverse reaction to other anticoagulant or antiplatelet agents.
  • History of any significant drug allergy (such as anaphylaxis or hepatotoxicity
  • Any investigational drug being administered during the study.
Drug, Administration of antineoplastic agent, Central venous catheter, Chemotherapy, Drug therapy
Acute lymphocytic leukemia, Cancer, Deep vein thrombosis, Leukemia, Lymphoma, Non-Hodgkin's lymphoma, Pulmonary embolism, Venous thrombosis
Acute lymphoid leukemia, B-cell lymphoma (clinical), Cancer treatment, Central venous catheterization, Cerebral venous sinus thrombosis, Chemotherapy, Circulatory system, Deep venous thrombosis, Hematopoietic system, Medical Oncology, Pulmonary embolism, T-cell lymphoma (clinical), apixaban, pegaspargase
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Mayo Clinic — Rochester, MN

MC1512: A Randomized, Double-Blinded, Placebo-Controlled Expansion Cohort Study of Disulfiram and Chemotherapy in Pancreas Cancer Patients

A Study of Disulfiram and Chemotherapy in Pancreas Cancer Patients

Aminah Jatoi
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-106845-P01-RST
15-003194
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Inclusion Criteria:

  • Adult males and females, age ≥ 18 years.
  • Cohort 1 (Dose Escalation): histologic or cytologic proof of any solid tumor that is incurable with no standard therapy that is likely to make a major impact on clinical outcomes.  
  • Cohort 2 (MTD) only: metastatic adenocarcinoma of the pancreas.  Prior systemic treatment for metastatic disease is allowed.
  • Cohort 2 (MTD) only: Patient is thought to be a short- or long-term candidate for chemotherapy in the opinion of the treating oncologist.
  • Laboratory values obtained ≤ 7 days prior to registration:
    • ANC ≥ 500/mm^3;
    • Platelet ≥ 100,000/mm^3;
    • Total bilirubin ≤ 2 x upper limit of normal (ULN);
    • AST (SGOT) ≤ 3 x ULN;
    • Creatinine ≥ 1.5 x ULN;
    • Hemoglobin ≥ 9.0 g/dL.
  • Cohort 2 (MTD) only: PT/INR ≤ 1.5 x ULN (only if muscle biopsy has not been waived, does not apply to non-Mayo sites that will not be conducting biopsies).
  • Ability to provide written informed consent.
  • Life expectancy ≥ 12 weeks.
  • Cohort 2 (MTD) only: Patient willing to undergo muscle biopsies at baseline and after 28 to 35 days of disulfiram/chemotherapy or chemotherapy/placebo therapy as required by the protocol unless the muscle biopsy has been waived after discussion with the PI. Muscle biopsies will not be required/performed at non-Mayo Clinic sites.
  • Cohort 2 (MTD) only:  Patient willing to have paraffin-embedded slides of the primary pancreas tumor or metastatic site; if available, sent to Mayo investigators for this study.
  • For women of childbearing potential only:
    • Negative urine or serum pregnancy test done ≤ 7 days prior to registration.
  • ECOG performance status (PS) 0, 1 or 2.
  • Able to swallow or have medication administered through a G-tube and absorb the medication.
  • Patient willing to complete a medication diary.
  • Patient agrees to use acceptable form of contraception during the study and for up to 30 days after last study drug dose if female partner is of childbearing potential.
  • Acceptable forms of contraception:
    • Latex condom (always used with spermicide);
    • Diaphragm (always used with spermicide);
    • Cervical cap (always used with spermicide).
  • Acceptable forms of secondary contraception, when used along with a barrier method:
    • Hormonal contraception methods, including pills, patches, rings, or injections except progestin-only containing pills (i.e.,“Mini-pill”);
    • Tubal ligation;
    • Partner’s vasectomy;
    • Intrauterine device (non-progesterone T);
    • Vaginal sponge (containing spermicide).
  • Other acceptable forms:
    • 100% commitment to abstinence
  • Unacceptable forms of contraception for women of childbearing potential:
    • Oral contraception containing progestins only;
    • IUD progesterone T;
    • Female condom;
    • Natural family planning (rhythm method) or breastfeeding;
    • Fertility awareness;
    • Withdrawal;
    • Cervical shield.


Exclusion Criteria:

  • Known standard therapy for the patient’s disease that is potentially curative.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, including localized infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements.
  • Untreated brain metastases.
  • Any of the following:
    • Pregnant women;
    • Nursing women.
  • This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation) or receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • Baseline of grade 2 or worse peripheral sensory neuropathy.
  • Receiving phenytoin.
  • Unable to abstain from alcohol for the duration of the study.

 

 

Drug, Chemotherapy, Drug therapy
Cancer, Pancreatic cancer
Chemotherapy, Digestive system, Malignant tumor of pancreas, Medical Oncology, Solid tumor configuration, disulfiram, gemcitabine
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A Prospective, Randomized, Blinded, Placebo-Controlled, Phase IIb Trial of an Autologous Tumor Lysate with Yeast Cell Wall Particles and Dendritic Cells Vaccine versus Unloaded Yeast Cell Wall Particles and Dendritic Cells in Stage III and Stage IV (Resected) Melanoma to Prevent Recurrence

A Study Comparing a Vaccine with or without an Autologous Tumor Lysate to Treat Stage III or IV Melanoma to Prevent Recurrence

James Jakub
All
18 years to 99 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-106949-P01-RST
15-004076
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Inclusion Criteria

  • 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0,1
  • AJCC stage III or IV completely resectable melanoma identified before surgery
  • Approximately 1 mg (1 cm3) of accessible and dispensable tumor that will not interfere with pathologic staging
  • Clinically disease-free after surgery
  • Completing SoC adjuvant therapy per NCCN guidelines to include chemotherapy, radiation therapy, and/or biologic therapy as clinically indicated (Consent #2 should be signed as close to completion of SoC as possible but may overlap completion by up to one month.)
  • Vaccinations initiated between 3 weeks and 3 months from completion of SoC multi-modality cancer care
  • Adequate organ function as determined by the following laboratory values
    • ANC ≥ 1,000/μL
    • Platelets ≥ 75,000/μL
    • Hgb ≥ 9 g/dL
    • Creatinine ≤ 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥ 50%
    • Total bilirubin ≤ 1.5 ULN
    • ALT and AST ≤ 1.5 ULN
  • For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)
  • Signed informed consent

Exclusion Criteria

  • Evidence of residual disease after surgery and SoC adjuvant therapies
  • Insufficient tumor available to produce vaccine
  • ECOG >2 performance status
  • Immune deficiency disease or known history of HIV, HBV, HCV
  • Receiving immunosuppressive therapy including chronic steroids, methotrexate, or other known immunosuppressive agents
  • Pregnancy (assessed by urine HCG)
  • Breast feeding
  • Active pulmonary disease requiring medication to include multiple inhalers (>2 inhalers and one containing steroids)
  • Involved in other experimental protocols (except with permission of the other study PI)
Biologic/Vaccine, Active immunization, Drug therapy
Cancer, Melanoma
Integumentary system, Malignant melanoma, Medical Oncology, Vaccination
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Mayo Clinic — Rochester, MN

A041501, A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL

Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

Mark Litzow
All
18 years to 39 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-106977-P01-RST
17-005534
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Inclusion Criteria:

REGISTRATION ELIGIBILITY CRITERIA (STEP 1)

  • Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible.
  • Patients with Burkitt type ALL are NOT eligible.
  • Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: flow cytometry is to be performed at the local reference lab and must include assessment of CD20 and CD22 positivity, as well as CD29 and CD22 anti-positivity.
  • No prior therapy except for limited treatment (< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine.
  • No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC.
  • Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; systemic chemotherapy must begin within 72 hours of this intrathecal therapy.
  • Patients receiving prior steroid therapy are eligible for study; the dose and duration of previous steroid therapy should be carefully documented on case report forms.
  • Not pregnant and not nursing; for women of childbearing potential only, a negative urine or serum pregnancy test done =< 7 days prior to registration is required.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    •Patients with down syndrome are excluded from this study.
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver.
  • Direct bilirubin =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver.
  • Calculated (calc.) creatinine clearance >= 50 mL/min by Cockcroft-Gault.

RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) 

  • Completion of remission induction therapy.
  • Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater than 25% lymphoblasts) will not be eligible to be randomized:
    • Rating: M0, M1; Blast Cells (%): 0-5.0;
    • Rating: M2; Blast Cells (%): 5.1-25.0;
    • Rating: M3; Blast Cells (%): > 25-50;
    • Rating: M4; Blast Cells (%): > 50.0; 
    • The term "blast cell" includes any cell that cannot be classified as a more mature normal element, and includes "leukemic cells," pathologic lymphocytes, and stem cells.
  • No ascites, effusions or significant edema.
  • Absolute neutrophil count (ANC) >= 1,000/mm^3.
  • Platelet count >= 100,000/mm^3.
  • Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert's syndrome.
  • Aspartate aminotransferase (AST) =< 8 x upper limit of normal (ULN).
  • Completion of first 12 weeks (12+ weeks) of maintenance therapy (Course V).
  • Patient has at least 24 weeks (24+ weeks) remaining before end of maintenance therapy (Course V).
  • Patient is in complete continuous first remission at entry into A041501-HO1.
  • Patient is receiving oral anti-metabolite chemotherapy during the maintenance phase of therapy; treatment plan must call for the following doses of antimetabolites: 6MP 75 mg/m2/day orally; methotrexate (MTX) 20 mg/m2/week orally (modification of 6 MP or MTX dosing based on laboratory or clinical parameters is acceptable).
  • Patient is able and willing to use the Medication Event Monitoring System (MEMS) TrackCap (e.g. not using a pillbox).
Biologic/Vaccine, Drug, Other, Procedure/Surgery, Administration of antineoplastic agent, Drug therapy
Cancer, Leukemia
B-cell acute lymphoblastic leukemia, Cancer treatment, Chemotherapy, Hematopoietic system, Medical Oncology, inotuzumab ozogamicin, Inotuzumab Ozogamicin
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Mayo Clinic — Rochester, MN

MC1562 Phase I Trial of Intravenous Administration of Vesicular Stomatitis Virus Genetically Engineered to Express Thyroidal Sodium Iodide Symporter (NIS) and Human Interferon Beta (hIFNb) in Patients With Metastatic or Recurrent Endometrial Cancer

VSV-hIFNbeta-NIS in Treating Patients With Stage IV or Recurrent Endometrial Cancer

Jamie Bakkum-Gamez
Female
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-106980-P01-RST
15-007000
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • Measurable Stage IVA, Stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma.
    • NOTE: Histologic confirmation of the original primary tumor is required. Patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, adenocarcinoma not otherwise specified (NOS).
    • NOTE: Measurable disease is defined by RECIST (version 1.1).
  • Group A only: Largest tumor diameter ≤ 5cm.
    • NOTE: Group B patients have no maximum tumor size.
  • The following laboratory values obtained ≤14 days prior to registration:
    • Absolute Neutrophil Count (ANC) ≥1500/μL;
    • Platelet Count (PLT) ≥00,000/μL;
    • Hemoglobin ≥10 g/dL;
    • Creatinine ≤2.0 mg/dL;
    • AST and ALT ≤2 x upper limit of normal (ULN);
      • NOTE: If baseline liver disease, Child Pugh score not exceeding Class A.
    • Total bilirubin ≤.5 x ULN;
    • INR/PT, aPTT ≤1.4 x ULN unless on therapeutic warfarin then INR/PT≤ 5.
  • Ability to provide written informed consent.
  • Willingness to return to Mayo Clinic in Rochester, Minnesota for follow-up.
  • Life expectancy ≥ 2 weeks.
  • ECOG performance status (PS) 0, 1, or 2.
  • Willingness to provide mandatory biological specimens for research purposes.
  • Prior therapy:
    • Any number of prior chemotherapy regimens and/or targeted therapies and/or prior external beam radiation therapy and/or prior hormonal therapy for endometrial cancer are allowed provided the last treatment was > 4 weeks prior to registration.
    • Vaginal brachytherapy may have been administered at any time prior to registration.


Exclusion Criteria:

  • Availability of and patient acceptance of curative therapy.
  • Active infection, including any active viral infection, ≤ 5 days prior to registration.
  • Active or latent tuberculosis or hepatitis.
  • Known untreated or symptomatic brain metastases.
  • Any of the following prior therapies:
    • Chemotherapy <4 weeks prior to registration;
    • Targeted biologic therapy<4 weeks prior to registration;
    • Immunotherapy <4 weeks prior to registration ;
    • Any viral or gene therapy prior to registration ;
    • External beam radiotherapy <4 weeks prior to registration.
    • NOTE: Vaginal brachytherapy may be performed at any time prior to registration.
  • New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or uncontrolled current cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia(SVT)).
  • Active CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology.
  • HIV positive test result or other immunodeficiency or immunosuppression.
  • History of hepatitis B or C or chronic hepatitis.
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-FDA approved indication and in the context of a research investigation).
  • Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids.
  • Exposure to household contacts ≤15 months old or household contact with known immunodeficiency.
  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant persons or persons of reproductive ability who are unwilling to use effective contraception;
    • Nursing persons.
  • Any other pathology or condition that the principal investigator deems to negatively impact treatment safety.
  • Any immunotherapy-related adverse events CTCAE >Grade 1 at the time of registration.
  • Receipt of a live virus vaccine ≤ 2 months prior to registration.

 

Biologic/Vaccine, Drug, Other, Procedure/Surgery, Administration of antineoplastic agent, Drug therapy
Recurrent cancer, Cancer, Endometrial cancer
Cancer treatment, Endometrial carcinoma, Medical Oncology, Recurrent malignant neoplastic disease, Reproductive system
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Mayo Clinic — Rochester, MN

Phase 1 Dose Escalation and Expansion Cohort Trial of Carboplatin and Gemcitabine with or without M6620 (VX-970) in First or Second Recurrence Platinum-Sensitive Epithelial Ovarian, Peritoneal, and Fallopian Tube Cancer

Carboplatin and Gemcitabine Hydrochloride With or Without VX-970 in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Andrea Wahner Hendrickson
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-106989-P01-RST
16-001556
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Inclusion Criteria:

  • Histologically confirmed high grade serous or endometrioid ovarian, peritoneal or fallopian tube malignancy that is metastatic and for which curative measures do not exist.  The histology can be confirmed from tissue that was taken at the time of diagnosis. A biopsy at the time of recurrence prior to enrollment on study is not required.
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) with conventional techniques or as ≥ 10 mm (≥ 1 cm) with spiral CT scan, MRI, or calipers by clinical exam. 
  • Patients enrolled in the phase 2 portion of the study will be required to have archival tumor tissue available for analysis and be willing to have a tumor biopsy at baseline (after registration and prior to starting study treatment) and at Cycle 1 Day 2.
  • Patients must have platinum sensitive disease and be in their first or second platinum sensitive recurrence. Platinum sensitive disease is defined as recurrence that occurred greater than six months after completion of their last line of platinum based therapy. No non-platinum regimens allowed. Prior therapy with PARP inhibitors as well as bevacizumab is allowed.
  • No more than two prior platinum based regimens. One regimen is defined as the interval of treatment from start of platinum based doublet to finish of that treatment course for the initial therapy or for the recurrent disease episode. If the nonplatinum agent is altered due to any reason other than disease progression, it counts as one regimen. For example, if a patient started on carboplatin and paclitaxel but developed a taxol reaction and was switched to carboplatin and Abraxane, this counts as one prior regimen.
  • Age ≥18 years.
  • Because no dosing or adverse event data are currently available on the use of M6620 (VX-970) in combination with carboplatin and gemcitabine in patients <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
  • ECOG performance status ≤ 2 (Karnofsky ≥ 60%, see Appendix A).
  • Life expectancy of greater than 6 months.
  • Patients must have normal organ and marrow function as defined below:
    • Leukocytes ≥3,000/mcL
    • Absolute Neutrophil Count (ANC) ≥1,500/mcL
    • Platelets ≥100,000/mcL
    • Total Bilirubin Within normal institutional limits
    • AST(SGOT)/ALT(SGPT) ≤ 2 × institutional upper limit of normal (ULN)
    • Creatinine Within normal institutional limits OR
    • Creatinine Clearance ≥ 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
  • Negative serum pregnancy test result for females of child bearing potential
    • Note: The effects of M6620 (VX-970) on the developing human fetus are unknown. For this reason and because DNA-damage response (DDR) inhibitors as well as other therapeutic agents used in this trial may have teratogenic potential, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 6 months after completion of M6620 (VX-970) administration. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consentdocument.
  • Of note, if appropriate per the FDA approved indications, patients may receive PARP inhibitor maintenance therapy after the primary endpoint has been reached, if desired. This therapy is not a part of the clinical trial and should be discussed and performed at the discretion of the patient and treating physician.


Exclusion Criteria:

  • Patients with platinum resistant disease or platinum sensitive disease that is past the first or second recurrence.
  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier, excluding alopecia. Patients with treatment related effects, such as peripheral neuropathy, that are grade 1 or less are eligible.
  • Prior exposure to gemcitabine.
  • Patients who are concurrently receiving any other investigational agents.
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to M6620 (VX-970), carboplatin, gemcitabine or to these specific compounds.
  • M6620 (VX-970) is primarily metabolized by CYP3A4; therefore, concomitant administration with strong inhibitors or inducers of CYP3A4 should be avoided. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently- updated medical reference for a list of drugs to avoid or minimize use of. Appendix B (Patient Drug Information Handout and Wallet Card) should be provided to patients. 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.
  • 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 studyrequirements.
  • Pregnant women are excluded from this study because M6620 (VX-970) as a DNA-damage response (DDR) inhibitor may have the 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 M6620 (VX-970), breastfeeding should be discontinued if the mother is treated with M6620 (VX-970). These potential risks also apply to the other agents used in this study, such as carboplatin and gemcitabine.
  • Patients with Li Fraumeni syndrome are excluded from the study as M6620 (VX-970) is a DDR inhibitor.
  • Addition of bevacizumab to the treatment in this study is not allowed. If the treating physician feels that the addition of bevacizumab is in the best interest of the patient, the patient should be treated with the FDA approved carboplatin/gemcitabine/bevacizumab regimen outside of the present study.

 

Drug, Other, Administration of antineoplastic agent, Drug therapy
Cancer, Fallopian tube cancer, Ovarian cancer, Peritoneal cancer, Recurrent cancer
Berzosertib [USAN], Cancer treatment, Carboplatin, Chemotherapy, Endometrioid carcinoma ovary, Gemcitabine [USAN:INN:BAN], Malignant tumor of fallopian tube, Medical Oncology, Primary high grade serous adenocarcinoma of ovary, Primary malignant neoplasm of fallopian tube, Primary malignant neoplasm of the peritoneum, Recurrent malignant neoplastic disease, Reproductive system, Secondary malignant neoplastic disease, carboplatin, gemcitabine
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Mayo Clinic Rochester, MN — Rochester, MN

Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction

Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer

Timothy Kozelsky
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-107002-P01-ALCL
18-002576
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Inclusion Criteria:

  • Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular). Patients with metaplastic breast cancer are not eligible.
  • Patients will be staged according to the TNM staging system.
  • For patients not receiving neoadjuvant chemotherapy, pathologic staging must be T0N1-2a, T1N1-2a, T2N1-2a, T3N0-2a, and all M0 status.
  • For patients receiving neoadjuvant chemotherapy, clinical pre-chemo staging and post mastectomy pathological staging is required for all patients. Patients who have received neoadjuvant chemotherapy and are pathologically cT0-2 and N0 are only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to the start of neoadjuvant chemotherapy. cT3N0 patients or ypT3N0 patients who receive neoadjuvant chemotherapy may be eligible based on clinical or pathological T stage, and do not require pathologically positive lymph nodes.
    • Note: Higher of the clinical or pathological T and N stage are used for final staging, if receiving neoadjuvant chemotherapy.
  • All patients with clinical, radiographic or pathological T4, N3 or involved internal mammary disease (N1b, N1c, and N2b) are not eligible.
  • No prior therapeutic radiation therapy to the chest, neck or axilla. Prior radioactive oral iodine is permitted.
  • No prior history of ipsilateral breast cancer (invasive disease or DCIS). LCIS and benign breast disease is allowed.
  • No history of prior or concurrent contralateral invasive breast cancer. Benign breast disease, LCIS or DCIS of contralateral breast is allowed.
  • No active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis.
  • Negative inked histologic margins from mastectomy pathology (no invasive cells at margin).
  • No significant post mastectomy complications in the ipsilateral or contralateral breast requiring an unplanned re-operation or admission for IV antibiotics. Re-operation for margins evaluation, nodal completion and routine reconstruction is acceptable.
  • Radiation oncologist intends to treat all target volumes and respect all normal tissues in accordance with the dosimetric constraints described (simulation before registration recommended).
  • Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements.
  • Radiation oncologist is NOT planning to utilize a chest wall/scar boost.
  • Patient must have undergone immediate reconstruction at the time of mastectomy or be planning to undergo reconstruction within 18 months after radiation.
  • If a tissue expander is utilized it needs to be a fluid filled expander, NO air expander (unless completely deflated) during radiation therapy.
  • For patients with diabetes, hemoglobin A1C test must have been performed ≤ 90 days prior to registration.
  • No co-existing medical conditions with life expectancy < 5 years.
  • No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix.
  • Negative serum or urine β-HCG in women of child-bearing potential ≤7 days prior to registration.
  • A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months.
  • Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy.
  • ECOG (Zubrod) Performance Status 0-1
  • Patient ≥ 18 years of age
  • Patients must be able to read and comprehend English, in order to be able to complete study questionnaires. However, patients participating through CCTG institutions who can read and comprehend French are eligible.

 


Exclusion Criteria:

  • None.

 

Radiation, Excision of breast tissue, Radiotherapy to breast
Breast cancer, Cancer
Breast cancer surgery, Cancer treatment, Malignant tumor of breast, Mastectomy, Medical Oncology, Radiation therapy, Radiation therapy for breast cancer
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Mayo Clinic Health System — Albert Lea, MN

Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction

Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer

Ron Smith
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-107002-P01-MAIJ
18-002576
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Inclusion Criteria:

  • Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular). Patients with metaplastic breast cancer are not eligible.
  • Patients will be staged according to the TNM staging system.
  • For patients not receiving neoadjuvant chemotherapy, pathologic staging must be T0N1-2a, T1N1-2a, T2N1-2a, T3N0-2a, and all M0 status.
  • For patients receiving neoadjuvant chemotherapy, clinical pre-chemo staging and post mastectomy pathological staging is required for all patients. Patients who have received neoadjuvant chemotherapy and are pathologically cT0-2 and N0 are only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to the start of neoadjuvant chemotherapy. cT3N0 patients or ypT3N0 patients who receive neoadjuvant chemotherapy may be eligible based on clinical or pathological T stage, and do not require pathologically positive lymph nodes.
    • Note: Higher of the clinical or pathological T and N stage are used for final staging, if receiving neoadjuvant chemotherapy.
  • All patients with clinical, radiographic or pathological T4, N3 or involved internal mammary disease (N1b, N1c, and N2b) are not eligible.
  • No prior therapeutic radiation therapy to the chest, neck or axilla. Prior radioactive oral iodine is permitted.
  • No prior history of ipsilateral breast cancer (invasive disease or DCIS). LCIS and benign breast disease is allowed.
  • No history of prior or concurrent contralateral invasive breast cancer. Benign breast disease, LCIS or DCIS of contralateral breast is allowed.
  • No active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis.
  • Negative inked histologic margins from mastectomy pathology (no invasive cells at margin).
  • No significant post mastectomy complications in the ipsilateral or contralateral breast requiring an unplanned re-operation or admission for IV antibiotics. Re-operation for margins evaluation, nodal completion and routine reconstruction is acceptable.
  • Radiation oncologist intends to treat all target volumes and respect all normal tissues in accordance with the dosimetric constraints described (simulation before registration recommended).
  • Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements.
  • Radiation oncologist is NOT planning to utilize a chest wall/scar boost.
  • Patient must have undergone immediate reconstruction at the time of mastectomy or be planning to undergo reconstruction within 18 months after radiation.
  • If a tissue expander is utilized it needs to be a fluid filled expander, NO air expander (unless completely deflated) during radiation therapy.
  • For patients with diabetes, hemoglobin A1C test must have been performed ≤ 90 days prior to registration.
  • No co-existing medical conditions with life expectancy < 5 years.
  • No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix.
  • Negative serum or urine β-HCG in women of child-bearing potential ≤7 days prior to registration.
  • A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months.
  • Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy.
  • ECOG (Zubrod) Performance Status 0-1
  • Patient ≥ 18 years of age
  • Patients must be able to read and comprehend English, in order to be able to complete study questionnaires. However, patients participating through CCTG institutions who can read and comprehend French are eligible.

 


Exclusion Criteria:

  • None.

 

Radiation, Excision of breast tissue, Radiotherapy to breast
Breast cancer, Cancer
Breast cancer surgery, Cancer treatment, Malignant tumor of breast, Mastectomy, Medical Oncology, Radiation therapy, Radiation therapy for breast cancer
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Mayo Clinic Health System — Mankato, MN

Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction

Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer

Kimberly Corbin
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-107002-P01-RST
18-002576
Show full eligibility criteria
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Inclusion Criteria:

  • Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular). Patients with metaplastic breast cancer are not eligible.
  • Patients will be staged according to the TNM staging system.
  • For patients not receiving neoadjuvant chemotherapy, pathologic staging must be T0N1-2a, T1N1-2a, T2N1-2a, T3N0-2a, and all M0 status.
  • For patients receiving neoadjuvant chemotherapy, clinical pre-chemo staging and post mastectomy pathological staging is required for all patients. Patients who have received neoadjuvant chemotherapy and are pathologically cT0-2 and N0 are only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to the start of neoadjuvant chemotherapy. cT3N0 patients or ypT3N0 patients who receive neoadjuvant chemotherapy may be eligible based on clinical or pathological T stage, and do not require pathologically positive lymph nodes.
    • Note: Higher of the clinical or pathological T and N stage are used for final staging, if receiving neoadjuvant chemotherapy.
  • All patients with clinical, radiographic or pathological T4, N3 or involved internal mammary disease (N1b, N1c, and N2b) are not eligible.
  • No prior therapeutic radiation therapy to the chest, neck or axilla. Prior radioactive oral iodine is permitted.
  • No prior history of ipsilateral breast cancer (invasive disease or DCIS). LCIS and benign breast disease is allowed.
  • No history of prior or concurrent contralateral invasive breast cancer. Benign breast disease, LCIS or DCIS of contralateral breast is allowed.
  • No active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis.
  • Negative inked histologic margins from mastectomy pathology (no invasive cells at margin).
  • No significant post mastectomy complications in the ipsilateral or contralateral breast requiring an unplanned re-operation or admission for IV antibiotics. Re-operation for margins evaluation, nodal completion and routine reconstruction is acceptable.
  • Radiation oncologist intends to treat all target volumes and respect all normal tissues in accordance with the dosimetric constraints described (simulation before registration recommended).
  • Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements.
  • Radiation oncologist is NOT planning to utilize a chest wall/scar boost.
  • Patient must have undergone immediate reconstruction at the time of mastectomy or be planning to undergo reconstruction within 18 months after radiation.
  • If a tissue expander is utilized it needs to be a fluid filled expander, NO air expander (unless completely deflated) during radiation therapy.
  • For patients with diabetes, hemoglobin A1C test must have been performed ≤ 90 days prior to registration.
  • No co-existing medical conditions with life expectancy < 5 years.
  • No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix.
  • Negative serum or urine β-HCG in women of child-bearing potential ≤7 days prior to registration.
  • A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months.
  • Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy.
  • ECOG (Zubrod) Performance Status 0-1
  • Patient ≥ 18 years of age
  • Patients must be able to read and comprehend English, in order to be able to complete study questionnaires. However, patients participating through CCTG institutions who can read and comprehend French are eligible.

 


Exclusion Criteria:

  • None.

 

Radiation, Excision of breast tissue, Radiotherapy to breast
Breast cancer, Cancer
Breast cancer surgery, Cancer treatment, Malignant tumor of breast, Mastectomy, Medical Oncology, Radiation therapy, Radiation therapy for breast cancer
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Mayo Clinic — Rochester, MN

APEC14B1, The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study

A Registry Called Every Child for Collecting Data and Biology Specimens on Younger Patients with Cancer

Wendy Allen-Rhoades
All
up to 25 years old
This study is NOT accepting healthy volunteers
0000-107030-P01-RST
15-008127
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Inclusion Criteria:

  • Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem.
  • Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority.
  • Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:
    • All cancer cases with an ICD-O histologic behavior code of two “2” (carcinoma in situ) or three “3” (malignant);
    • All neoplastic lesions of the central nervous system regardless of behavior; i.e., benign, borderline or malignant;
  • The following other benign/ borderline conditions:  
    • Mesoblastic nephroma;
    • Teratomas (mature and immature types);
    • Myeloproliferative diseases including transient myeloproliferative disease;
    • Langerhans cell histiocytosis;
    • Lymphoproliferative diseases;
    • Desmoid tumors;
    • Gonadal stromal cell tumors.
  • Subjects must be ≤ 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating NCTN) therapeutic study, for which there is a higher upper age limit.
  • All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study. Parents will be asked to sign a separate consent for their own biospecimen submission.
  • If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow. Consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1.
Cancer, Pediatric brain tumor, Brain tumor
Malignant neoplastic disease, Medical Oncology, Nervous system
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Mayo Clinic — Rochester, MN

MC1376 Phase I Trial to Evaluate the Safety and Efficacy of Intratumoral and Intravenous Injection of Vesicular Stomatitis Virus Expressing Human Interferon Beta, and Tyrosinase Related Protein 1 (VSV-IFNb-TYRP1) in Patients with Metastatic Ocular Melanoma and Previously Treated Patients with Unresectable Stage III/IV Cutaneous Melanoma

A Study to Evaluate the Safety and Effectiveness of Intratumoral and Intravenous Injection of Vesicular Stomatitis Virus Expressing Human Interferon Beta, and Tyrosinase Related Protein 1 (VSV-IFNb-TYRP1) in Patients with Metastatic Ocular Melanoma and Previously Treated Patients with Unresectable Stage III/IV Cutaneous Melanoma

Matthew Block
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-107036-P01-RST
18-000991
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic (Stage IV) melanoma, including metastatic ocular melanoma, with estimated largest tumor diameter ≤ 5cm and ≤ 2 tumors ≥ 3 to ≤ 5 cm diameter.
  • Cutaneous melanoma patients only:
    • At least one prior FDA approved systemic therapy in the metastatic setting; and disease progression after immune checkpoint inhibitors.
    • If tumor is BRAF-mutated, previous BRAF- and/or MEK-targeted therapies are required.
      • NOTE:  For ocular melanoma patients no current standard of care exists, so patients are permitted to be treated in1st line setting.
  • Measurable disease by any imaging modality as defined by RECIST (version 1.1).
    • NOTE: Disease that is measurable by physical examination only is not eligible.
  • Injectable disease (i.e., suitable for direct injection or through the use of ultrasound guidance) defined as:
    • At least 1 injectable and safely accessible cutaneous, subcutaneous, or nodal melanoma lesion ≥5 mm in longest diameter for metastatic cutaneous or mucosal melanoma;
    • At least one safely accessible liver metastasis for patients with metastatic ocular melanoma.
  • Patients with metastatic ocular melanoma must meet all of the additional inclusion criteria:
    • No more than 25% overall tumor involvement of the liver by MRI imaging;
    • Child Pugh Score A;
    • Absence of ascites;
    • No portal vein thrombosis.
  • Have resolution of all previous treatment-related toxicities to Grade 1 severity or lower.
  • The following laboratory values obtained ≤ 14 days prior to registration:
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
    • Platelet count ≥ 100,000/mm^3;
    • Hemoglobin ≥ 9.0 g/dL (without need for hematopoietic growth factor or transfusion support);
    • Alanine aminotransferase (ALT) ≤ 2.5 x ULN;
    • Aspartate transaminase (AST) ≤ 2.5 x ULN;
    • Total bilirubin ≤ 1.5 x ULN;
    • PT ≤ 1.5 x ULN (or international normalization ratio [INR] ≤ 1.4) or PTT/aPTT ≤ULN;
    • Serum creatinine within institutional limits of normal (≤ ULN).
  • Life expectancy of ≥ 12 weeks.
  • ECOG Performance Status (PS) 0 or 1.
  • Willing and have the ability to comply with scheduled visits (including geographical proximity), treatment plans, laboratory tests, and other study procedures.
  • Willing to provide all biological specimens as required by the protocol.
  • Including fresh tissue for biomarker analysis (metastatic melanoma cohort with accessible injectable lesions only).
    • NOTE: Patients with cutaneous melanoma and accessible cutaneous/ subcutaneous lesions will have one lesion biopsied prior to the subject receiving the first dose of study treatment on Day 1 of Cycle 1 and the biopsy will be repeated on the injected target lesion and an uninjected lesion where possible post-virus treatment on Day 3.
    • NOTE: Repeat samples may be required if adequate tissue is not obtained.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
    • NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Willing to use an adequate method of contraception (see Appendix III) from the first dose of study medication through 120 days after the last dose of study medication, for persons of childbearing potential or persons able to father a child only.


Exclusion Criteria:

  • Known standard therapy for the patient’s disease that is potentially curative or definitely capable of extending life expectancy.
  • Any of the following prior therapies:
    • Prior chemotherapy ≤ 2 weeks prior to registration;
    • Prior immunotherapy (monoclonal antibodies) ≤ 3 weeks prior to registration;
    • Prior experimental agent ≤ 2 weeks prior to registration;
    • Prior radiation therapy ≤ 2 weeks prior to registration.
  • Need for concurrent chemotherapy, immunotherapy, radiotherapy, ablation therapy or any ancillary therapy considered investigational (used for a non-FDA approved indication or in the context of a research investigation).
  • Minor surgical or interventional procedure ≤ 7 days prior to registration.
  • Major surgical procedure ≤ 21 days prior to registration.
  • History or evidence of melanoma associated with immunodeficiency states (e.g., hereditary immune deficiency, organ transplant, or leukemia, requires concomitant treatment with immunosuppressive agents, including CTLA-4 agonists, or chronic oral or systemic steroid medication including physiological replacement doses for adrenal insufficiency.
  • History of or plan for splenectomy or splenic irradiation.
  • History or evidence of central nervous system (CNS) metastases.
  • Active skin lesions (open wounds, severe rash, herpetic lesions, etc.).
  • Prior non-oncology vaccine therapies used for the prevention of infectious disease ≤ 28 days prior to registration.
  • Requires concomitant treatment with therapeutic anticoagulants.
  • Known history of active tuberculosis.
  • Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Known acute or chronic hepatitis B or hepatitis C infection (requires negative test).
  • Metastatic ocular melanoma patients only: liver radioembolization ≤ 90 days prior to registration.
  • No other active second malignancy other than non-melanoma skin cancers and in situ cervical cancers within 35 years of registration.
    • NOTE: A second malignancy is not considered active if all treatment for that malignancy is completed and the patient has been disease-free for at least 3 years prior to registration.
  • No uncontrolled intercurrent illness including, but not limited to:
    • ongoing or active infection;
    • symptomatic congestive heart failure;
    • unstable angina pectoris;
    • uncontrolled symptomatic cardiac arrhythmia;
    • uncontrolled hypertension (defined as blood pressure >160/90).
  • New York Heart Association classification III or IV, known symptomatic coronary artery disease or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias.
  • Active CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology.
  • Pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of study treatment.
  • Person of childbearing potential who is unwilling to use two (2) highly effective methods of contraception during study treatment and through 120 days after the last dose of study treatment.
  • Person able to father a child who is unwilling to use a highly effective method of contraception during study treatment and through 120 days after the last dose of study treatment.

 

Drug, Administration of antineoplastic agent, Drug therapy, Intralesional injection, Medication administration: intravenous
Cancer, Eye melanoma, Melanoma, Skin cancer
Cancer treatment, Integumentary system, Malignant melanoma of eye, Malignant melanoma of skin, Medical Oncology
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RU011501I: Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination With Folate Receptor Alpha Peptide Vaccine With GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients With Triple Negative Breast Cancer

Multi-epitope Folate Receptor Alpha Peptide Vaccine, Sargramostim, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer

Kathryn Ruddy
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-107041-P01-RST
17-003039
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NOTE: Waivers to eligibility criteria are not allowed per ACCRU policy.

Inclusion Criteria:

  • Female, ≥ 18 years old.
  • Resected unilateral or bilateral primary carcinoma of the breast without clinical evidence of metastatic disease (after neoadjuvant chemotherapy and/or adjuvant chemotherapy), negative for estrogen receptor (ER) and progesterone receptor (PR) (cut-off for positivity is > 10% positive tumor cells with nuclear staining), and negative for HER2 as defined by one of the four situations delineated below: 
    • HER2 immunohistochemistry (IHC) expression of 0 or 1+ and in-situ hybridization non-amplified;
    • HER2 IHC expression of 0 or 1+ and in-situ hybridization not done;
    • HER2 IHC expression of 2+ and in-situ hybridization non-amplified; 
    • IHC not done and in-situ hybridization non-amplified. 
      • Note: central review is not required. 
      • Note: If biopsy and surgical specimens are discordant from each other with regard to ER, PR, and/or HER2 status, a patient will be allowed to enroll assuming at least one of the specimens meets the above criteria and no endocrine therapy use is planned going forward.
  • Completed planned breast CANCER surgeries, any radiation therapy, and any chemotherapy, whichever is last, ≥ 90 days but not ≥ 546 days prior to randomization. 
    • Note: Reconstructive and prophylactic surgeries are allowed after randomization (during study treatment).
  • Patient had at least one of the following: 
    • Biopsy or surgery-proven regional node involvement by cancer;
    • T1c, T2, T3, or T4 (disease with inflammatory disease allowed) identified at the time of surgery or clinically identified prior to neoadjuvant chemotherapy);
    • No complete response to neoadjuvant chemotherapy (those who did achieve complete response are still eligible if a pre-chemotherapy regional nodal biopsy identified cancer or if the pre-chemotherapy tumor measured > 1 cm).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1.
  • The following laboratory values obtained ≤14 days prior to randomization:
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3 obtained ≤ 14 days prior to randomization;
    • Platelet count ≥ 75,000/uL obtained ≤ 14 days prior to randomization;
    • Aspartate transaminase (AST) ≤ 3 x upper limit of normal (ULN) obtained ≤ 14 days prior to randomization;
    • Creatinine ≤ 1.5 x ULN obtained ≤ 14 days prior to randomization.
  • Negative serum pregnancy test done ≤ 14 days prior to randomization, for women of childbearing potential only. 
  • Provide informed written consent.
  • Willing to return to enrolling institution for follow-up.
  • Willing to provide tissue and blood samples for correlative research studies.


Exclusion Criteria:
 

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant women. 
    • Nursing women.
    • Women of childbearing potential who are unwilling to employ adequate contraception.
  • Clinical evidence of local recurrence or distant metastases.
    • Note: New primary tumors are allowed, both contralaterally and ipsilaterally, but a prior breast cancer must have been more than 5 years beforehand 
  • Known hypersensitivity reaction to GM-CSF.
  • Active autoimmune disease that has required systemic treatment ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to randomization.
    • Note: replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment; patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded; patients with Celiac disease controlled with diet modification are not excluded.
  • 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.
    • NOTE: Localized fungal or viral infections including of the skin, nails, mouth, and genital area are allowed.
  • History of other cancer < 5 years prior to consent (except non-melanoma skin cancer or carcinoma in situ of the uterine cervix), or current receipt of treatment for another cancer (e.g., monoclonal antibody, small molecule pathway inhibitor).
  • Treatment with systemic corticosteroid or immune-modulators ≤ 7 days prior to randomization. 
  • Concurrent treatment with other experimental drugs or any other systemic anticancer therapy (due to unknown drug-vaccine potential interactions).
    • NOTE: aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), statins, and other medications commonly used to treat nononcologic, non-autoimmune conditions are allowed.
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. 
  • Prior or concurrent use of trastuzumab.
  • Prior or concurrent use of a PD-1 or PD-L1 checkpoint inhibitor including pembrolizumab unless the use was ≥ 3 months prior to randomization.

Eligibility last updated 9/2/21. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Drug therapy
Breast cancer, Cancer, Triple-negative breast cancer
Chemotherapy, Chemotherapy for breast cancer, Medical Oncology, Triple-negative breast cancer, cyclophosphamide, sargramostim, Cancer treatment, Cyclophosphamide, Sargramostim, Virotherapy
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Mayo Clinic — Rochester, MN

TTI-621-01 - A Phase 1a/1b Dose Escalation and Expansion Trial of TTI-621, a Novel Biologic Targeting CD47, in Subjects With Relapsed or Refractory Hematologic Malignancies and Selected Solid Tumors

A Trial of TTI-621 for Patients With Hematologic Malignancies and Selected Solid Tumors

Stephen Ansell
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-107078-P01-RST
16-000585
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Inclusion Criteria:

Phase 1a Escalation (Completed and now Closed)

  • Histologically documented, advanced lymphoma after the failure of at least 2 prior therapies with at least one site of measurable disease (≥ 1.5 cm in the long axis or ≥ 1.0 cm in both the long and short axis). Additionally, subjects with NHL (indolent and aggressive B-cell lymphomas) should have failed CD20-targeted therapy.
  • Adequate hematologic status (in the absence of transfusion and growth factor support for at least 28 days), defined as:
    • absolute neutrophil count (ANC) ≥ 1.5 x 109/L;
    • platelets ≥ 75 x 109/L;
    • hemoglobin ≥ 10 g/dL.

Phase 1b Expansion (Selected Cohorts Currently Open for Parts 2 and 3)

  • Advanced measurable malignancy documented by histology, cytology, flow cytometry, fluorescent in situ hybridization (FISH) or polymerase chain reaction (PCR) methodology in one of the following categories:
    • (closed) Small cell lung cancer (SCLC) (measurable disease by the Response Evaluation Criteria in Solid Tumors [RECIST], Version 1.1).
    • Histologically documented, advanced lymphoma after the failure of at least 2 prior systemic therapies with at least one site of measurable disease (≥ 1.5 cm in the long axis or ≥ 1.0 cm in both the long and short axis). Additionally, subjects with CD20-positive NHL (indolent and aggressive B-cell lymphomas) should have failed CD20-targeted therapy:
      • Indolent B-cell lymphoma;
      • Aggressive B-cell lymphoma;
      • Classic Hodgkin lymphoma.
        • Patients with cHL should have failed at least one checkpoint inhibitor therapy before enrolling to the nivolumab combination cohort. 
      • Peripheral T-cell lymphoma ([PTCL] as defined by mature T- and NK-cell neoplasms per WHO and CTCL), having failed at least 1 prior systemic therapy. Subjects with PTCL must have at least 1 site of measurable disease (≥ 1.5 cm in the long axis or ≥ 1.0 cm in both the long and short axis).
      • CTCL (both MF and SS):
        • Failed at least 2 prior systemic therapies for CTCL. Systemic therapy does not include local radiation therapy or topical agents;
        • Malignancy is measurable per global CTCL criteria (Olsen, 2011);
        • History of histologically-documented diagnosis of CTCL stage IIB to IVB (Olsen, 2011).
      • (closed) B-cell or T-cell acute lymphoblastic leukemia (ALL):
        • First or greater bone marrow relapse from complete remission; or
        • Any bone marrow relapse after allogeneic transplant; or
        • Absence of complete remission after 2 induction attempts employing standard regimens; or
        • Ph+ B-ALL if subjects are intolerant to or ineligible to receive tyrosine kinase inhibitor therapy or have progressed after at least one line of this therapy.
      • (closed) CLL: subjects should have failed at least 2 prior therapies, including CD20-targeted therapy.
      • (closed) Multiple myeloma (MM): subjects should have failed at least 3 prior therapies, including an immunomodulatory drug (IMID) and proteasome inhibitor-based therapy and have measurable disease as defined as 1 or more of the following:
        • serum M-protein > 0.5g/dl; and/or
        • urine M-protein > 200 mg/24 hours; and/or
        • in subjects who do not meet these criteria, serum free light chains (FLC) > 100 mg/L (involved light chain) and abnormal ratio (FLC kappa/FLC lambda);
        • biopsy-proven plasmacytoma.
      • (closed) AML, with the exception of AML M3 using the French American British (FAB) classification (i.e., acute promyelocytic leukemia [APL]).
      • (closed) MDS of WHO classifications RAEB-1 (refractory anemia with excess blasts) and RAEB-2.
      • (closed) BCR/ABL1-negative myeloproliferative neoplasm (MPN) or myeloproliferative/myelodysplastic overlap neoplasm (MPN/MDS) per the revised 2016 WHO criteria, including:
        • chronic phase (CP) (defined as peripheral blood and bone marrow <10% blasts) primary myelofibrosis or post-essential;
          • if the diagnosis is Myelofibrosis-CP, must have Dynamic International Prognostic Scoring System (DIPSS) intermediate-2/high risk disease (Passamonti et al., 2010) and either be: 1) intolerant/resistant to ruxolitinib or 2) ineligible for ruxolitinib therapy, as determined by the treating Investigator.
        • accelerated phase/blast phase MPN (MPN-AP/BP) (defined as either a peripheral blood or bone marrow with ≥10% blasts);
          • if the diagnosis is MPN-AP/BP, must have progressive/resistant disease after treatment with a DNA methyl transferase 1 (DNMT1) inhibitor therapy (e.g. azacitidine or decitabine), as determined by the treating Investigator.
        • chronic myelomonocytic leukemia (CMML) -1 or 2 characterized by:
          • > 1x109/L monocytes and 2-19% blasts in peripheral blood or Auer rods; and
          • dysplasia in ≥1hematopoietic line and 5-19% marrow blasts or Auer rods.
        • (closed) Subjects with MPN or MPN/MDS must not be eligible to proceed with hematopoietic stem cell transplantation (HSCT) and must have:
          • for MPN, an indication to treat with cytoreductive drugs (e.g. hydroxyurea, anagrelide, interferon, ruxolutinib, etc.), according to the judgment of the treating physician;
          • for MPN, documentation of inadequate response or intolerance to first line therapy, which includes at least one cytoreductive drug (e.g. hydroxyurea, anagrelide, interferon, ruxolutinib, etc.);
          • for CMML, documentation of inadequate response or intolerance to first line therapy, which includes at least one hypomethylating agent.
  • Hematologic status as follows (transfusions not permissible to achieve these levels within 14 days prior to the first dosing of study drug):
    • o ANC ≥1 x 109/L (not applicable to subjects with AML, ALL, MDS, or MPN/MDS);
    • o platelets ≥75 x 109/L (≥0 x 109/L if the patient has bone marrow involvement);
    • o hemoglobin ≥9 g/dL.

Phase 1b Expansion (Dose Optimization Part 4)

  • Histologically confirmed diagnosis of CTCL (both Mycosis Fungoides and Sezary Syndrome):
    • Failed at least 2 prior systemic therapies for CTCL (systemic therapy does not include local radiation therapy or topical agents);
    • Malignancy is measurable per global CTCL criteria (Olsen, 2011);
    • History of histologically-documented diagnosis of CTCL stage IB to IVB (Olsen, 2011).
  • Hematologic status as follows (transfusions not permissible to achieve these levels within 14 days prior to the first dosing of study drug):
    • ANC ≥ 1 x 109/L;
    • platelets ≥ 75 x 109/L;
    • hemoglobin ≥ 9 g/dL.

Both Phases

  • Male or female 18 years of age or older.
  • Availability of fresh or archived tumor tissue for immunohistochemical studies. Archival tissue may be used provided it was obtained subsequent to the last prior anti-cancer therapy. For subjects with SS, peripheral blood is acceptable.
  • Relapsed or refractory disease that has previously progressed on, or is currently progressing on standard anticancer therapy or for whom no other approved conventional therapy exists.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Adequate coagulation function, defined as:
    • International Normalized Ratio (INR) < 1.5 x the upper limit of normal (ULN) for that laboratory;
    • partial thromboplastin time < 1.5 x ULN;
    • subjects receiving anticoagulation therapy must be on a stable dose with monitoring studies within therapeutic range per local institutional standards
  • Adequate hepatic function, defined as:
    • total bilirubin < 1.5 x ULN unless considered due to Gilbert’s disease;
    • alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 1.5 x ULN or < 3 x ULN with documented liver metastases.
  • Adequate renal function, defined as estimated serum creatinine clearance > 30 mL/minute calculated using the Cockcroft-Gault equation.
  • Recovery from the toxicities of previous anticancer drugs or radiotherapy to Grade 0 or 1 (or to baseline grade if condition was pre-existing).
  • Commitment from male and female subjects of reproductive potential to use, from the time of screening through 60 days after the last dose of TTI-621, either:
    • one highly effective method of contraception, including hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants), intrauterine device (IUD) or intrauterine system (IUS), vasectomy, or tubal ligation; OR
    • at least 2 effective methods of contraception, including male condom, female condom, cervical cap, diaphragm, or contraceptive sponge; OR
    • abstain from sex during study participation and for 60 days after the last dose of TTI-621.


Exclusion Criteria:

Both Phases

  • (AML cohort closed) AML M3 by FAB classification (APL).
  • Known, current central nervous system disease involvement or untreated brain metastases.
  • Investigational agent or any anticancer drug within 14 days prior to planned start of treatment (with the exception of hydroxyurea in subjects with MPN, MPN/MDS, ALL or AML).
  • Allogeneic transplant within 30 days prior to the planned start of treatment or subjects with active graft-vs-host disease with the exception of Grade 1 skin involvement.
  • Prior anti-CD47 therapy, with the exception of prior TTI-621 therapy delivered intratumorally only.
  • Major surgery within 28 days prior to planned start of treatment.
  • Use of irreversible antiplatelet/anticoagulant agents within 7 days prior to planned start of treatment (except subjects with thrombocytosis where low dose aspirin is being used to reduce the risk of thrombosis); use of low dose aspirin (≤81 mg/day) and selected, reversible anticoagulants are permitted (low molecular weight heparin, heparin, warfarin and dabigatran).
  • History of hemolytic anemia or bleeding diathesis.
  • Uncontrolled infection requiring systemic antibiotics/antivirals/antifungals.
  • Chronic use of systemic corticosteroids of more than 20 mg per day of prednisone or equivalent; enrollment of post-transplant subjects who are on corticosteroids for graft-vs-host disease prophylaxis requires approval of the Medical Monitor. CTCL patients who are on a stable dose of medium or low potency topical corticosteroids for at least 4 weeks prior to study entry may continue its use on study at the same dose.
  • Known hypersensitivity to any component of study drug.
  • Positive serum pregnancy test in females of child-bearing potential or current breastfeeding.
  • Significant cardiovascular disease such as symptomatic congestive heart failure (New York Heart Association Class III or IV), symptomatic coronary artery disease, myocardial infarction within the last 6 months, unstable arrhythmia requiring treatment, unstable angina, or prolonged QTc interval > 480 milliseconds (Grade 2 or higher) (QTc interval calculation at the discretion of the Investigator).
  • Active hepatitis B or C or a history of HIV infection.
  • Other significant medical condition unrelated to the primary malignancy that would compromise subject’s safety or ability to comply with protocol requirements.
  • Inability for the subject to complete protocol requirements, such as geographic considerations, psychiatric disorders, or other compliance concerns.
  • Prior Grade 4 rituximab infusion-related reaction (rituximab combination arm only).
  • Active autoimmune disease or history of autoimmune disease that might recur (nivolumab combination arm only); subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll.

Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Leukemia, Lymphoma, Multiple myeloma, Recurrent cancer
Cancer treatment, Hematopoietic system, Malignant tumor of lymphoid hemopoietic and related tissue, Medical Oncology
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MC1682, Ixazomib, Lenalidomide, and Dexamethasone for Patients With POEMS Syndrome

Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome

Angela Dispenzieri
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-107095-P01-RST
16-002976
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Inclusion Criteria:

  • POEMS syndrome requiring therapy, previously treated or untreated
  • Plasma vascular endothelial growth factor (VEGF) > 2 x upper limit of normal (ULN)
  • Presence of a plasma cell clone (any of the following):
    • Monoclonal protein in the serum or urine
    • Measurable light chains by free light chain assay
    • Measurable plasmacytoma
    • Monoclonal plasma cells in bone marrow
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2, or 3
  • Absolute neutrophil count (ANC) ≥ 1000/uL
  • Platelet count (PLT) ≥ 75,000/uL
  • Total bilirubin ≤ 2.0 mg/dL unless due to known Gilbert's disease
    • NOTE: If total bilirubin is > 2 mg/dL, a direct bilirubin should be performed and must be < 1.5 mg/dL for Gilbert's to be diagnosed
  • Alanine aminotransferase (ALT/serum glutamic pyruvic transaminase [SGPT]) and aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase [SGOT]) ≤ 3 x upper limit of normal (ULN)
  • Creatinine clearance ≥ 30 mL/min/1.73 m^2 (as determined by Cockcroft-Gault equation)
  • Negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
    • NOTE: Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
  • Birth control
    • Female patients of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
      • NOTE: Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
    • Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
      • NOTE: Abstinence is acceptable (for either males or females) if this is the established and preferred method of contraception for the subject
  • Willing to adhere to the guidelines of the Revlimid REMS (formerly known as RevAssist) program
    • NOTE: The counseling must be documented
  • Provide written informed consent
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
    • Note: During the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
  • No contraindication to be on a minimum of 81 mg aspirin a day (or other anticoagulant therapy as prescribed) for thromboembolism prophylaxis
  • Willing to provide mandatory blood and bone marrow samples for research purposes
  • Ability to complete questionnaire(s) by themselves or with assistance


Exclusion Criteria:

  • Recent prior chemotherapy:
    • Newly diagnosed patients (regardless of group); any prior chemotherapy for POEMS with the following exceptions:
      • Prior immunomodulators like azathioprine, cyclosporin, and/or corticosteroids are not exclusionary therapies if used for prior diagnosis of chronic inflammatory demyelinating polyneuropathy
      • Prior chemotherapy directed at a "myeloproliferative neoplasm" like hydroxyurea is not exclusionary
    • Previously treated patients (group 2)
      • Alkylators (e.g. melphalan, cyclophosphamide) ≤ 28 days prior to registration
      • Anthracyclines ≤ 28 days prior to registration
      • High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide), or proteosome inhibitors (e.g. ixazomib or bortezomib) ≤ 28 days prior to registration
  • Requirement for concomitant high dose corticosteroids
    • EXCEPTION: Patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for adrenal insufficiency, rheumatoid arthritis, etc
  • Receiving any other investigational agent, which would be considered as a treatment for the primary neoplasm
  • Participation in other clinical trials, including those with other investigational agents not included in this trial, ≤ 30 days prior to registration and throughout the duration of this trial
  • Prior refractoriness to proteasome inhibitor or immunomodulatory drugs (IMiD)
  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Other active malignancy ≤ 3 years prior to registration
    • EXCEPTIONS: Non-melanotic skin cancer, ductal carcinoma in-situ, or carcinoma-in-situ of the cervix
    • NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
  • 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, e.g. uncontrolled infection (infection requiring systemic antibiotic therapy or other serious infection ≤ 14 days prior to registration); or uncompensated heart or lung disease
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
  • Systemic treatment with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort ≤ 14 days prior to registration
  • History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Radiotherapy ≤ 14 days prior to registration
  • Major surgery ≤ 14 days prior to registration
  • Failure to fully recover (i.e. ≤ grade 1 adverse event [AE]) from the reversible effects of prior chemotherapy
  • Known allergy to any of the study medications, their analogs, or excipients in the various formulations of any agent
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of the study drugs including difficulty swallowing
  • Ongoing or active systemic infection or active hepatitis B or C virus infection
Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy
POEMS syndrome, Plasma cell disorders
Dexamethasone, Hematopoietic system, Immune system, Ixazomib, Lenalidomide, POEMS syndrome, dexamethasone, ixazomib, lenalidomide
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AAML1531, Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome (AAML1531)

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome

Carola Arndt
All
91 days to 3 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-107109-P01-RST
15-009083
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Inclusion Criteria:

  • Patients must have constitutional trisomy 21 (Down syndrome) or trisomy 21 mosaicism (by karyotype or fluorescence in situ hybridization [FISH])
  • Patients with previously untreated de novo AML who meet the criteria for AML with ≥ 20% bone marrow blasts as set out in the World Health Organization (WHO) Myeloid Neoplasm classification
  • Patients with cytopenias and/or bone marrow blasts who do not meet the criteria for the diagnosis of AML (WHO Myeloid Neoplasm classification) because of < 20% marrow blasts are eligible if they meet the criteria for a diagnosis of myelodysplastic syndrome (MDS)
  • Patients with a history of transient myeloproliferative disorder (which may or may not have required chemotherapy intervention), who:
    • Are > 8 weeks since resolution of transient myeloproliferative disease (TMD) with ≥ 5% blasts, OR
    • Patients sho have an increasing blast count (≥ 5%) in serial bone marrow aspirates performed at least 4 weeks apart
  • Children who have previously received chemotherapy, radiation therapy or any anti-leukemic therapy are not eligible for this protocol, with the exception of cytarabine for the treatment of TMD
  • There are no minimal organ function requirements for enrollment on this study
    • Note: Previous cardiac repair with sufficient cardiac function is not an exclusion criteria
  • Each patient's parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human subjects research must be met


Exclusion Criteria:

  • Patients with promyelocytic leukemia (French-American-British [FAB] M3)
  • Prior therapy
    • Patients ≤ 30 days from the last dose of cytarabine used for treatment
Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy
Acute myelogenous leukemia, Cancer, Down syndrome, Leukemia, Myelodysplastic syndromes, Plasma cell disorders
Acute myeloid leukemia, disease, Cancer treatment, Chemotherapy, Childhood myelodysplastic syndrome, Complete trisomy 21 syndrome, Hematopoietic system, Immune system, Medical Oncology, Myeloid leukemia co-occurrent with Down syndrome, Transient abnormal myelopoiesis co-occurrent with Down syndrome
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Mayo Clinic — Rochester, MN

A021502, Randomized Trial of Standard Chemotherapy Alone or Combined With Atezolizumab as Adjuvant Therapy for Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

Mina Hanna
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-107116-P01-ALCL
17-008658
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Inclusion Criteria:

  • Histologically proven stage III colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C)
  • Presence of deficient (d) DNA mismatch repair (dMMR); MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR; dMMR may be determined either locally or by site-selected reference lab; Note: loss of MLH1 and PMS2 commonly occur together; formalin-fixed paraffin-embedded (FFPE) tumor tissue is required for subsequent retrospective central confirmation of dMMR status
  • Patients with testing that did not show dMMR (loss of MMR protein) are not eligible to participate; patients whose tumors show MSI-H by polymerase chain reaction (PCR)-based assay are not eligible to participate unless they also have MMR testing by IHC and are found to have dMMR (i.e. loss of one or more MMR proteins)
  • Patients who are known to have Lynch syndrome and have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2) are eligible to participate
  • Tumors must have been completely resected; in patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented; positive radial margins are not excluded as long as en bloc resection was performed; proximal or distal margin positivity is excluded
  • Entire tumor must be in the colon (rectal involvement is an exclusion); surgeon confirmation that entire tumor was located in the colon is required only in cases where it is important to establish if the tumor is a colon versus (vs.) rectal primary
  • Based upon the operative report and other source documentation, the location of the primary tumor will be categorized as proximal or distal to the splenic flexure (distal includes), and further categorization will be as follows: cecum/ascending, descending, sigmoid colon, or rectosigmoid colon
  • No evidence of residual involved lymph node disease or metastatic disease at the time of registration based on clinician assessment of imaging; the treating physician will determine if incidental lesions on imaging require workup to exclude metastatic disease; if based on review of images, the treating physician determines the patient to be stage III, then the patient is eligible
  • No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for colon cancer except for one cycle of mFOLFOX6
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • For women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required; 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)
  • Absolute neutrophil count (ANC) >= 1500 mm^3
  • Platelet count >= 100,000 mm^3; platelets >= 75,000 required for patients who received cycle 1 of mFOLFOX6 prior to registration
  • Creatinine =< 1.5 x upper limit of normal (ULN) or
  • Calculated creatinine clearance >= 45 mL/min by Cockcroft-Gault equation
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) except in the case of Gilbert disease
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
  • Thyroid-stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible
  • No active known autoimmune disease, including colitis, inflammatory bowel disease (i.e. ulcerative colitis or Crohn's disease), rheumatoid arthritis, panhypopituitarism, adrenal insufficiency
  • No known active hepatitis B or C
    • Active hepatitis B can be defined as:
      • Hepatitis B virus surface antigen (HBsAg) detectable for > 6 months;
      • Serum hepatitis B virus (HBV) DNA 20,000 IU/ml (105 copies/ml); lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B virus e antigen (HBeAg)-negative chronic hepatitis B
      • Persistent or intermittent elevation in ALT/AST levels
      • Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation
    • Active hepatitis C can be defined as:
      • Hepatitis C antibody (AB) positive AND
      • Presence of hepatitis C virus (HCV) RNA
  • Excluded if known active pulmonary disease with hypoxia defined as:
    • Oxygen saturation < 85% on room air, or
    • Oxygen saturation < 88% despite supplemental oxygen
  • No grade >= 2 peripheral motor or sensory neuropathy
  • Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:
    • A stable regimen of highly active anti-retroviral therapy (HAART)
    • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
    • A CD4 count above 250 cells/mcL, and an undetectable HIV viral load on standard PCR-based tests
  • No other planned concurrent investigational agents or other tumor directed therapy (chemotherapy, radiation) while on study
  • No systemic daily treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of registration
  • No known history of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
  • No known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab formulation
  • No known allergy to 5-fluorouracil, oxaliplatin, or leucovorin

Drug, Administration of antineoplastic agent, Chemotherapy, Combination therapy, Drug therapy, Immunotherapy for cancer
Cancer, Colon cancer
Atezolizumab, Biological therapy for cancer, Cancer treatment, Chemotherapy, DNA mismatch repair, Digestive system, Fluorouracil [USAN:USP:INN:BAN:JAN], Leucovorin, Malignant tumor of colon, Medical Oncology, Oxaliplatin, atezolizumab, fluorouracil, leucovorin, oxaliplatin
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Mayo Clinic Health System — Albert Lea, MN

A021502, Randomized Trial of Standard Chemotherapy Alone or Combined With Atezolizumab as Adjuvant Therapy for Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

Amrit Singh
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-107116-P01-MAIJ
17-008658
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Histologically proven stage III colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C)
  • Presence of deficient (d) DNA mismatch repair (dMMR); MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR; dMMR may be determined either locally or by site-selected reference lab; Note: loss of MLH1 and PMS2 commonly occur together; formalin-fixed paraffin-embedded (FFPE) tumor tissue is required for subsequent retrospective central confirmation of dMMR status
  • Patients with testing that did not show dMMR (loss of MMR protein) are not eligible to participate; patients whose tumors show MSI-H by polymerase chain reaction (PCR)-based assay are not eligible to participate unless they also have MMR testing by IHC and are found to have dMMR (i.e. loss of one or more MMR proteins)
  • Patients who are known to have Lynch syndrome and have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2) are eligible to participate
  • Tumors must have been completely resected; in patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented; positive radial margins are not excluded as long as en bloc resection was performed; proximal or distal margin positivity is excluded
  • Entire tumor must be in the colon (rectal involvement is an exclusion); surgeon confirmation that entire tumor was located in the colon is required only in cases where it is important to establish if the tumor is a colon versus (vs.) rectal primary
  • Based upon the operative report and other source documentation, the location of the primary tumor will be categorized as proximal or distal to the splenic flexure (distal includes), and further categorization will be as follows: cecum/ascending, descending, sigmoid colon, or rectosigmoid colon
  • No evidence of residual involved lymph node disease or metastatic disease at the time of registration based on clinician assessment of imaging; the treating physician will determine if incidental lesions on imaging require workup to exclude metastatic disease; if based on review of images, the treating physician determines the patient to be stage III, then the patient is eligible
  • No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for colon cancer except for one cycle of mFOLFOX6
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • For women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required; 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)
  • Absolute neutrophil count (ANC) >= 1500 mm^3
  • Platelet count >= 100,000 mm^3; platelets >= 75,000 required for patients who received cycle 1 of mFOLFOX6 prior to registration
  • Creatinine =< 1.5 x upper limit of normal (ULN) or
  • Calculated creatinine clearance >= 45 mL/min by Cockcroft-Gault equation
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) except in the case of Gilbert disease
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
  • Thyroid-stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible
  • No active known autoimmune disease, including colitis, inflammatory bowel disease (i.e. ulcerative colitis or Crohn's disease), rheumatoid arthritis, panhypopituitarism, adrenal insufficiency
  • No known active hepatitis B or C
    • Active hepatitis B can be defined as:
      • Hepatitis B virus surface antigen (HBsAg) detectable for > 6 months;
      • Serum hepatitis B virus (HBV) DNA 20,000 IU/ml (105 copies/ml); lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B virus e antigen (HBeAg)-negative chronic hepatitis B
      • Persistent or intermittent elevation in ALT/AST levels
      • Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation
    • Active hepatitis C can be defined as:
      • Hepatitis C antibody (AB) positive AND
      • Presence of hepatitis C virus (HCV) RNA
  • Excluded if known active pulmonary disease with hypoxia defined as:
    • Oxygen saturation < 85% on room air, or
    • Oxygen saturation < 88% despite supplemental oxygen
  • No grade >= 2 peripheral motor or sensory neuropathy
  • Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:
    • A stable regimen of highly active anti-retroviral therapy (HAART)
    • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
    • A CD4 count above 250 cells/mcL, and an undetectable HIV viral load on standard PCR-based tests
  • No other planned concurrent investigational agents or other tumor directed therapy (chemotherapy, radiation) while on study
  • No systemic daily treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of registration
  • No known history of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
  • No known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab formulation
  • No known allergy to 5-fluorouracil, oxaliplatin, or leucovorin

Drug, Administration of antineoplastic agent, Chemotherapy, Combination therapy, Drug therapy, Immunotherapy for cancer
Cancer, Colon cancer
Atezolizumab, Biological therapy for cancer, Cancer treatment, Chemotherapy, DNA mismatch repair, Digestive system, Fluorouracil [USAN:USP:INN:BAN:JAN], Leucovorin, Malignant tumor of colon, Medical Oncology, Oxaliplatin, atezolizumab, fluorouracil, leucovorin, oxaliplatin
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Mayo Clinic Health System — Mankato, MN

A021502, Randomized Trial of Standard Chemotherapy Alone or Combined With Atezolizumab as Adjuvant Therapy for Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

Frank Sinicrope
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-107116-P01-RST
17-008658
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Histologically proven stage III colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C)
  • Presence of deficient (d) DNA mismatch repair (dMMR); MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR; dMMR may be determined either locally or by site-selected reference lab; Note: loss of MLH1 and PMS2 commonly occur together; formalin-fixed paraffin-embedded (FFPE) tumor tissue is required for subsequent retrospective central confirmation of dMMR status
  • Patients with testing that did not show dMMR (loss of MMR protein) are not eligible to participate; patients whose tumors show MSI-H by polymerase chain reaction (PCR)-based assay are not eligible to participate unless they also have MMR testing by IHC and are found to have dMMR (i.e. loss of one or more MMR proteins)
  • Patients who are known to have Lynch syndrome and have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2) are eligible to participate
  • Tumors must have been completely resected; in patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented; positive radial margins are not excluded as long as en bloc resection was performed; proximal or distal margin positivity is excluded
  • Entire tumor must be in the colon (rectal involvement is an exclusion); surgeon confirmation that entire tumor was located in the colon is required only in cases where it is important to establish if the tumor is a colon versus (vs.) rectal primary
  • Based upon the operative report and other source documentation, the location of the primary tumor will be categorized as proximal or distal to the splenic flexure (distal includes), and further categorization will be as follows: cecum/ascending, descending, sigmoid colon, or rectosigmoid colon
  • No evidence of residual involved lymph node disease or metastatic disease at the time of registration based on clinician assessment of imaging; the treating physician will determine if incidental lesions on imaging require workup to exclude metastatic disease; if based on review of images, the treating physician determines the patient to be stage III, then the patient is eligible
  • No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for colon cancer except for one cycle of mFOLFOX6
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • For women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required; 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)
  • Absolute neutrophil count (ANC) >= 1500 mm^3
  • Platelet count >= 100,000 mm^3; platelets >= 75,000 required for patients who received cycle 1 of mFOLFOX6 prior to registration
  • Creatinine =< 1.5 x upper limit of normal (ULN) or
  • Calculated creatinine clearance >= 45 mL/min by Cockcroft-Gault equation
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) except in the case of Gilbert disease
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
  • Thyroid-stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible
  • No active known autoimmune disease, including colitis, inflammatory bowel disease (i.e. ulcerative colitis or Crohn's disease), rheumatoid arthritis, panhypopituitarism, adrenal insufficiency
  • No known active hepatitis B or C
    • Active hepatitis B can be defined as:
      • Hepatitis B virus surface antigen (HBsAg) detectable for > 6 months;
      • Serum hepatitis B virus (HBV) DNA 20,000 IU/ml (105 copies/ml); lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B virus e antigen (HBeAg)-negative chronic hepatitis B
      • Persistent or intermittent elevation in ALT/AST levels
      • Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation
    • Active hepatitis C can be defined as:
      • Hepatitis C antibody (AB) positive AND
      • Presence of hepatitis C virus (HCV) RNA
  • Excluded if known active pulmonary disease with hypoxia defined as:
    • Oxygen saturation < 85% on room air, or
    • Oxygen saturation < 88% despite supplemental oxygen
  • No grade >= 2 peripheral motor or sensory neuropathy
  • Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:
    • A stable regimen of highly active anti-retroviral therapy (HAART)
    • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
    • A CD4 count above 250 cells/mcL, and an undetectable HIV viral load on standard PCR-based tests
  • No other planned concurrent investigational agents or other tumor directed therapy (chemotherapy, radiation) while on study
  • No systemic daily treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of registration
  • No known history of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
  • No known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab formulation
  • No known allergy to 5-fluorouracil, oxaliplatin, or leucovorin

Drug, Administration of antineoplastic agent, Chemotherapy, Combination therapy, Drug therapy, Immunotherapy for cancer
Cancer, Colon cancer
Atezolizumab, Biological therapy for cancer, Cancer treatment, Chemotherapy, DNA mismatch repair, Digestive system, Fluorouracil [USAN:USP:INN:BAN:JAN], Leucovorin, Malignant tumor of colon, Medical Oncology, Oxaliplatin, atezolizumab, fluorouracil, leucovorin, oxaliplatin
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Mayo Clinic — Rochester, MN

MC1671 Pilot Study to Assess Heterogeneity of the Blood Brain Barrier in Patients With CNS Malignancy

Blood Brain Barrier Differences in Patients With Brain Tumors Undergoing Surgery

Jann Sarkaria
All
18 years and over
This study is NOT accepting healthy volunteers
0000-107130-P01-RST
16-007782
Show full eligibility criteria
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • Clinical and radiographic evidence suggesting CNS malignancy.
  • Suspected newly diagnosed, local, or intracranial recurrence of primary brain tumor OR Previously untreated or treated brain metastasis.
  • Willing to undergo a neurosurgical resection of CNS lesion at Mayo Clinic Rochester.
  • Able to have MRI imaging with gadolinium contrast (e.g., no cardiac pacemaker, defibrillator, renal failure).
  • Females of childbearing potential must have a negative pregnancy test done < 14 days prior to registration.
  • Provide written informed consent.
  • Willing to provide tissue and blood samples for research purposes
  • For patients having a study-specific surgical planning MRI only.  The following lab values obtained ≤ 30 days prior to registration:
    • Creatinine (eGFR ≥ 30).


Exclusion Criteria:

  • Vulnerable populations: pregnant women, prisoners, mentally handicapped.
  • Unable to undergo a biopsy of CNS lesion.
  • Documented drug allergy to cefazolin, levetiracetam, or other study drugs, or other contraindication to use these drugs in the pre-operative setting (e.g., patient is already on another anti-seizure medication which precludes the clinical indication for pre-operative levetiracetam).
  • Patients who are unable to swallow tablets if study drug is administered by mouth.
  • Patients who are at risk for impaired absorption of oral medication if study drug is administered by mouth. Note: This includes but not limited to, refractory vomiting, gastric resection/bypass, and duodenal/jejunal resection.
  • Pregnant or nursing women.
    • Note: Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects with chemotherapy. There is also a potential risk for AEs in nursing infants secondary to treatment of the mother with these drugs, so breastfeeding should be discontinued for the duration of the study.

 

Brain tumor, Cancer
Brain tumor surgery, Medical Oncology, Nervous system
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Mayo Clinic — Rochester, MN

MC1684 Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients with Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic/Dendritic Cell Neoplasms

A Study to Evaluate VSV-hIFNbeta-NIS to Treat Patients with Relapsed/Refractory Multiple Myleoma, Acute Myeloid Leukemia, or T-cell Lymphoma

Nabila Bennani
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-107174-P01-RST
16-005474
Show full eligibility criteria
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Inclusion Criteria:
​​​​​​

  • Age ≥ 18 years.
  • Relapsed or refractory:
    • Groups A, B, or C: Multiple myeloma (MM) previously treated with an IMID, a proteosome inhibitor and an alkylating agent; OR
    • Groups A or B: Acute myeloid leukemia (AML), excluding acute promyelocytic leukemia (PML-RARA rearranged- AML-M3); either primary refractory or relapsed/refractory disease after at least two front line chemotherapy regimens (note: induction and consolidation chemotherapy is considered one line of therapy). Diagnosis based on 2008 WHO criteria; OR
    • Groups A, B, or C: Relapsed T-cell lymphoma (TCL) or the following types: peripheral T-cell lymphoma-NOS (PTCL-NOS); angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell (ALCL), and cutaneous TCL (CTCL) of mycosis fungoides (MF). Patients should have failed standard therapy and in the case of PTCL-NOS, AITL, and ALCL either have failed or be ineligible for high-dose therapy with autologous stem cell transplant.
  • All diseases/All Groups: The following laboratory values obtained ≤ 14 days prior to registration:
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST);
    • ≤ 2 times upper limit of normal (ULN);
    • Creatinine ≤ 2.0 mg/dL;
    • Direct bilirubin ≤ 1.5 x ULN;
    • INR/PT and aPTT ≤ 1.5 x ULN.
  • If baseline liver disease, Child Pugh score not exceeding Class A.
  • Negative pregnancy test for persons of child-bearing potential.

For multiple myeloma only

  • Measurable disease of multiple myeloma as defined by at least ONE of the following:
    • Serum monoclonal protein ≥ 1.0 g/dL by protein electrophoresis;
    • ≥ 200 mg of monoclonal protein in the urine on 24-hour electrophoresis;
    • Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio.
  • The following laboratory values obtained ≤ 14 days prior to registration:
    • ANC ≥ 1000/μL;
    • PLT ≥ 100,000/μL;
    • Hemoglobin ≥ 8.5 g/dl.

For AML only

  • The following laboratory values obtained ≤ 14 days prior to registration:
    • No ANC restriction;
    • PLT ≥ 10,000/μL (transfusion to get platelets ≥ 10,000 is allowed);
    • Hemoglobin ≥ 7.5 g/dl.
  • Absence of uncompensated disseminated intravascular coagulation (DIC- as diagnosed by standard ISTH criteria).

For TCL only

  • The following laboratory values obtained ≤ 14 days prior to registration:
    • ANC ≥1,000/μL;
    • PLT ≥ 100,000/μL;
    • Hemoglobin ≥ 8.5 g/dl.
  • Measurable disease by CT or MRI:
    • Must have at least one lesion that has a single diameter of > 2 cm or tumor cells in the blood > 5 x10^9/L.
    • NOTE: Skin lesions can be used if the area is > 2 cm in at least one diameter and photographed with a ruler and the images are available in the medical record.
  • Absence of active CNS involvement.
    • NOTE: Pre-enrollment lumbar puncture not mandatory.
  • Ability to provide written informed consent.
  • Willingness to return to Mayo Clinic for follow-up.
  • Life expectancy ≥ 12 weeks.
  • ECOG performance status (PS) 0, 1, or 2.
  • Willing to provide mandatory biological specimens for research purposes.


Exclusion Criteria:

  • Availability of and patient acceptance of curative therapy.
  • Uncontrolled infection.
  • Active tuberculosis or hepatitis, or history of hepatitis B or C, or chronic hepatitis.
  • Any of the following prior therapies:
    • Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) ≤ 2 weeks prior to registration;
    • Immunotherapy (monoclonal antibodies) ≤ 4 weeks prior to registration;
    • Experimental agent in case of AML or TCL within 4 half-lives of the last dose of the agent;
    • New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or SVT).
  • Active CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology. In case of AML active CNS involvement as detected by lumbar puncture or neuro-imaging (only to be done if clinically indicated).
  • HIV positive test result or other immunodeficiency or immunosuppression.
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-FDA approved indication and in the context of a research investigation).
    • NOTE: In AML, the concurrent use of hydroxyurea to help control proliferative counts is allowed throughout the treatment protocol.
    • NOTE: In TCL, patients may use topical emollients or corticosteroids, acetic acid soaks, etc. to control pruritis and prevent infection. No topical chemotherapy is allowed (no topical nitrogen mustard).
  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant women or women of reproductive ability who are unwilling to use effective contraception;
    • Nursing women;
    • Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment.
  • Prior allogeneic bone marrow transplant.

AML only:  Current disseminated intravascular coagulopathy (DIC).

  • Additional exclusion criteria for Group A (low tumor burden) ONLY:

AML only:  Acute promyelocytic leukemia (PML-RARA rearranged- AML-M3).

AML only

  • AML with > 30% circulating blasts and > 50% bone marrow blasts.
  • Multiple myeloma only: ≥ 15% plasmas cells or plasmacytoma > 5cm in largest diameter.

TCL only:  Any mass ≥ 5cm.

  • Additional exclusion criteria for Group C (combination with cyclophosphamide) ONLY:
    • Diagnosis of AML.

 

 

 

Biologic/Vaccine, Procedure/Surgery, Active immunization
Acute myelogenous leukemia, Cancer, Leukemia, Lymphoma, Multiple myeloma
Acute myeloid leukemia, Hematopoietic system, Medical Oncology, Multiple myeloma, T-cell lymphoma (clinical), Acute myeloid leukemia, disease
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Mayo Clinic — Rochester, MN

Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesothelioma to Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study) (ATOMIC)

A Study in Subjects with Malignant Pleural Mesothelioma to Assess ADI-PEG 20 with Pemetrexed and Cisplatin

Aaron Mansfield
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-107194-P01-RST
16-007453
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Inclusion Criteria:

  • Histologically proven advanced MPM of biphasic or sarcomatoid histology. Biphasic MPM is defined using the World Health Organization's international histological classification of tumors as containing an epithelial and a sarcomatoid component with each component comprising at least 10% of the tumor
  • Naïve to prior chemotherapy or immunotherapy (i.e., this is a first-line systemic therapy study).
  • MPM tumor sample for determination of ASS1 status. ASS1-deficiency is not required for study entry at study start, but tumor sample for ASS1 status is required. This study will employ an adaptive biomarker-driven design with an interim analysis to be conducted at the end of the phase 2 portion. The interim analysis will evaluate the treatment effect of ADI PEG 20 in combination with pemetrexed and cisplatin on overall survival (OS) in the overall population (biphasic and sarcomatoid histology patients) and pre-defined subpopulation of biomarker-positive patients (ASS1-deficient subpopulation). Thus, ASS1 deficiency may be required for the phase 3 portion of the study, pending the interim analysis. ASS1-deficiency, demonstrated on tissue specimen (cytospin samples are not acceptable), will be defined in the laboratory manual. If archived tissue is not sufficient or not available, then tissue must be obtained by biopsy.
  • Measurable disease as assessed by modified RECIST for MPM for thoracic disease and RECIST 1.1 for extra-thoracic disease.
  • ECOG performance status of 0
    •1.
  • Predicted life expectancy of at least 12 weeks.


Exclusion Criteria:

  • Radiotherapy (except for palliative reasons) the previous two weeks before.
  • Ongoing toxic manifestations of previous treatments.
  • Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery).
  • Major thoracic or abdominal surgery from which the patient has not yet recovered.
  • Serious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior.
  • Known to be serologically positive for human immunodeficiency virus (HIV). Testing to determine possible infection status is not required.
Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Lung cancer, Mesothelioma
1,2-Diaminocyclohexaneplatinum II citrate, Cancer treatment, Chemotherapy, Deficiency of argininosuccinate synthase, Malignant mesothelioma of pleura, Medical Oncology, Pegargiminase [USAN:INN], Pemetrexed, Respiratory system, cisplatin, pemetrexed
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Mayo Clinic — Rochester, MN

MC1685, Phase I/II Study of Dendritic Cell Therapy Delivered Intratumorally After Cryoablation and Anti-PD-1 Antibody (Pembrolizumab) for Patients With Non-Hodgkin Lymphoma

Dendritic Cell Therapy, Cryosurgery, and Pembrolizumab in Treating Patients With Non-Hodgkin Lymphoma

Yi Lin
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-107195-P01-RST
16-005856
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • Histological confirmation of biopsy-proven non-Hodgkin lymphoma, excluding chronic lymphocytic leukemia, primary central nervous system (CNS) lymphoma and Burkitt's lymphoma.
    • Note: small lymphocytic lymphoma (SLL) is allowed.
  • Patients with indolent non-Hodgkin lymphoma (NHL) must have had ≥ 1 regimen of rituximab-containing regimen.
    • Note: this includes follicular lymphoma (FL), marginal lymphoma and mucosa-associated lymphoid tissue (MALT).
  • Patient with aggressive NHL must have received prior therapy
    •at a minimum:
    • Anti-CD20 monoclonal antibody unless tumor is CD20 negative; and
    • An anthracycline containing regimen;
    • Transformed FL must have had therapy for FL and be refractory to chemotherapy for DLBCL.
  • Chemotherapy refractory disease in aggressive NHL is defined as:
    • Stable disease of ≤ 12 months or progressive disease as best response to most recent chemotherapy containing regimen;
    • Disease progression or recurrence ≤ 12 months of prior autologous stem cell transplantation (SCT).
  • Patients with aggressive NHL must have failed autologous hematopoietic stem cell transplantation (HSCT), or are ineligible or not consenting to autologous HSCT.
  • Patient must have at least 3 measurable lesions that are ≥ 1.5 cm in one dimension; one of the lesions must be ≥ 2.0 cm and is amenable to image-guided cryoablation and multiple vaccine injections as determined by interventional radiology and principal investigator (PI) (including tumors that can be safely accessed using imaging guidance and treated with minimal risk to adjacent structures).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2.
  • Absolute neutrophil count (ANC) ≥ 1000/mm^3.
  • Absolute lymphocyte count ≥ 200/mm^3.
  • The following laboratory values obtained ≤ 14 days prior to registration:
    • Platelet count ≥ 50,000/mm^3;
    • Hemoglobin ≥ 8.0 g/dL;
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN), unless due to Gilbert's disease;
    • Aspartate transaminase (AST/serum glutamic-oxaloacetic transaminase [SGOT]) and alanine transaminase (ALT/serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x ULN;
    • Creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min for subject with creatinine ˃ 1.5 x institutional ULN.
  • Negative serum pregnancy test for women of childbearing potential ≤ 7 days prior to registration; Note: a second pregnancy test may be required ≤ 72 hours prior to receiving the first dose of study medication.
  • Negative human immunodeficiency virus (HIV), hepatitis B and C, and tuberculosis (TB) test.
  • Provide written informed consent.
  • Willing to return to the enrolling institution for follow-up (during active treatment and active monitoring phase of the study).
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Willing to provide tissue and blood samples for research purposes.
  • Willing to use adequate contraception while on the study and until 120 days after the last dose of study drug.


Exclusion Criteria:

  • Any of the following:
    • Pregnant women;
    • Nursing women.
  • 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.
  • Serious non-malignant disease such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations or other conditions which in the opinion of the investigator would compromise protocol objectives.
  • Currently receiving or have received any other investigational agent considered as a treatment for the primary neoplasm ≤ 28 days or within 4 half-lives (whichever is shorter) of the agent prior to registration.
  • History of other primary malignancy requiring systemic treatment within 6 months of protocol enrollment; patients must not be receiving chemotherapy or immunotherapy for another cancer; patients must not have another active malignancy requiring active treatment with the following acceptable EXCEPTIONS:
    • Basal cell carcinoma, squamous cell carcinoma, or melanoma of the skin that has undergone or will undergo potentially curative therapy;
    • In situ cervical cancer that has undergone or will undergo potentially curative therapy.
  • Prior allogeneic bone marrow or peripheral blood stem cell transplantation.
  • Prior autologous bone marrow or peripheral blood stem cell transplantation ≤ 100 days prior to registration or if recovery from the transplant is inadequate.
  • Major surgery other than diagnostic surgery ≤ 4 weeks prior to registration.
  • Prior chemotherapy or radiation therapy ≤ 2 weeks prior to registration or who has not recovered (i.e., to ≤ grade 1 or baseline) from an adverse event due to the previously administered therapy.
  • History of hypersensitivity and anaphylactoid reactions to pneumococcal vaccine or any component of the formulation, including diphtheria toxoid.
  • Active autoimmune disease such as Crohn's disease, rheumatoid arthritis, Sjogrens' disease, systemic lupus erythematosis, or similar conditions requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease/syndrome difficult to control in the past.
    • EXCEPTIONS:
      • Vitiligo or resolved childhood asthma/atopy;
      • Intermittent use of bronchodilators or local steroid injections;
      • Hypothyroidism stable on hormone replacement;
      • Diabetes stable with current management;
      • History of positive Coombs test but no evidence of hemolysis;
      • Psoriasis not requiring systemic treatment;
      • Conditions not expected to recur in the absence of an external trigger.
  • Coagulopathy, including the use of Coumadin or heparin anticoagulants that cannot be discontinued for the cryoablation procedure.
    • NOTE: heparin for line patency without detectable lab abnormalities for coagulation will be allowed.
  • Corticosteroid use ≤ 2 weeks prior to registration.
    • NOTE: patients must be off corticosteroids for at least 2 weeks prior to registration; this includes oral, IV, subcutaneous, or inhaled route of administration; patients on chronic corticosteroid for adrenal insufficiency or other reasons may enroll if they receive less than 10 mg/day of prednisone (or equivalent).
  • Active CNS malignancy.
  • Evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Received a live vaccine ≤ 30 days prior to registration.
  • New York Heart Association classification III or IV cardiovascular disease or recent myocardial infarction or unstable angina pectoris or cardiac arrhythmia ≤ 30 days prior to registration.
Biologic/Vaccine, Procedure/Surgery, Administration of antineoplastic agent, Cryosurgery, Drug therapy, Immunotherapy for cancer, Intralesional injection
Cancer, Cutaneous t-cell lymphoma, Lymphoma, Non-Hodgkin's lymphoma, Waldenstrom macroglobulinemia
Biological therapy for cancer, Cancer treatment, Cryoablation for cancer, Hematopoietic system, Integumentary system, Medical Oncology, Non-Hodgkin's lymphoma (clinical), Pembrolizumab [USAN:INN], pembrolizumab, Cellular therapy
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Mayo Clinic — Rochester, MN

A071601, Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas

Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma

Evanthia Galanis
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-107211-P01-RST
17-010499
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Inclusion Criteria:

  • Pre-registration: Patients must have local diagnosis of papillary craniopharyngioma and have tissue slides available for submission to central pathology review; central pathology review will include immunohistochemistry (IHC) testing for BRAF V600E mutation (VE1 clone) and beta-catenin IHC (membranous, non-nuclear pattern) if needed to confirm diagnosis of papillary craniopharyngioma
  • Histologically proven papillary craniopharyngioma as documented by central pathology review with positive BRAF V600E mutation by IHC
  • Measurable disease and/or non-measurable disease
    • Measurable disease, defined as bidimensionally measurable lesions with clearly defined margins by magnetic resonance imaging (MRI) scans, with a minimum diameter of 10 mm in both dimensions
    • Progressive disease required in cohort B, defined as an increase in the bidirectional area by 25% within the past 13 months after surgery or radiation; progressive or recurrent disease is not required in cohort A, but is allowed provided it is a new diagnosis and patient has not received prior treatment.
  • Prior treatment
    • Cohort A: No prior therapy received other than surgery
    • Cohort B: Prior radiation therapy required (any type of prior radiation is allowed)
      • For patients treated with external beam radiation therapy, interstitial brachytherapy or radiosurgery, an interval of >= 3 months must have elapsed from completion of radiation therapy to registration
      • Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity attributed to radiation with exception of alopecia, fatigue
    • For patients enrolling on Cohort A or Cohort B:
      • For patients treated with surgery, an interval of >= 21 days must have elapsed prior to registration
      • No prior treatment with BRAF or MEK inhibitors
      • Steroid dosing stable for at least 4 days prior to registration
  • Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
  • ECOG performance status =< 2
  • Comorbid conditions
    • No evidence of active bleeding, bleeding diathesis, or hemoptysis (>= 1/2 teaspoon of red blood) =< 8 weeks prior to registration
    • No evidence of intracranial hemorrhage =< 4 weeks prior to registration
    • Patients who have experienced thromboembolic event within 6 months prior to registration must be on stable therapeutic anticoagulation for at least 4 weeks prior to registration
    • No symptomatic congestive heart failure (New York Heart Association class II, III, or IV) within 6 months prior to registration
    • No current unstable angina or uncontrolled arrhythmia
    • No uncontrolled hypertension at time of registration (blood pressure [BP] > 150/95 despite antihypertensive therapy)
    • No known history of prolonged QT syndrome
    • No known history of ventricular arrhythmia within 6 months of registration
    • No known history of uveitis or iritis =< 4 weeks prior to registration
    • No known history of or evidence of retinal pathology that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration within 12 months of registration
    • No known history of chronic lung disease
  • Concomitant medications
    • Chronic concomitant treatment with strong CYP3A4 inducers or CYP3A4 inhibitors is not allowed; patients must discontinue the drug at least 14 days prior to study registration
    • Chronic concomitant treatment with CYP1A2 substrate is not allowed; patients must discontinue the drug at least 14 days prior to study registration
  • Absolute neutrophil count >= 1500/mm^3
  • Platelets >= 100,000/mm^3
  • Creatinine =< 1.5 mg/dL OR creatinine clearance >= 45mL/min
  • Bilirubin =< 1.5 upper limit of normal (ULN)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 ULN
Drug, Other, Administration of antineoplastic agent, Drug therapy
Brain tumor, Cancer, Craniopharyngioma
Cancer treatment, Cobimetinib [USAN:INN], Craniopharyngioma, Medical Oncology, Nervous system, Vemurafenib [USAN:INN], cobimetinib, vemurafenib
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Mayo Clinic — Rochester, MN