Health Studies MN

Within 


Search Results

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

612 Study Matches

Sorting by: Relevance Distance

A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients With Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

A Study to Compare Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian or Primary Peritoneal Cancer

Andrea Wahner Hendrickson
Female
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-101134-P01-RST
19-009074
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

  • Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up.
  • All women will, by definition, be considered menopausal due to surgical removal of both ovaries prior to trial enrollment.
  • Patients must have newly diagnosed, stage II-IV low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinoma) of the ovary or peritoneum. Tumors must be assessed for nuclear p53 staining.
  • Appropriate stage for study entry based on the following diagnostic workup: 
    • History/physical examination within 14 days prior to registration; 
    • Contrast-enhanced imaging of the chest, abdomen and pelvis within 28 days prior to registration. 
  • Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal (< 1 cm diameter residual disease/nodule) or suboptimal residual disease (> 1 cm diameter residual disease/nodule) status allowed. 
  • Patients must have undergone a bilateral salpingo-oophorectomy. 
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to registration .
  • Patients must be within ≤ 8 weeks of primary cytoreductive surgery prior to initial randomization.
  • Patients must be able to take per oral (P.O.) medications. 
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl (within 14 days prior to registration). 
  • Platelets greater than or equal to 100,000 cells/mcl (within 14 days prior to registration).
  • Creatinine less than or equal to 1.5 x upper limit of normal (ULN) (within 14 days prior to registration).
  • Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible if there is no hydronephrosis and the estimated creatinine clearance (CCr) is >= 30 ml/min (within 14 days prior to registration).
  • Bilirubin less than or equal to 1.5 x ULN (within 14 days prior to registration).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3 x ULN (within 14 days prior to registration).
  • Alkaline phosphatase less than or equal to 2.5 x ULN (within 14 days prior to registration). 
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information.


Exclusion Criteria:
 

  • Patients with concomitant invasive malignancy or a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the past five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol. 
  • Patients may not have received neoadjuvant chemotherapy or radiotherapy for the treatment of this disease. 
  • Patients may not have received previous hormonal therapy for the treatment of this disease. 
  • Patients with known hypersensitivity to letrozole or hypersensitivity/intolerance to carboplatin/paclitaxel therapy. 
  • Patients with severe cardiac disease. 
  • Myocardial infarction or unstable angina within 6 months prior to registration. 
  • New York Heart Association (NYHA) Class II or greater congestive heart failure. 
  • Patients with known central nervous system metastases.
  • Patients with active or uncontrolled systemic infection. 
  • Patients with ≥ Grade 2 baseline neuropathy. 
  • Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration.
  • Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Hormone therapy
Cancer, Ovarian cancer, Peritoneal cancer
Cancer treatment, Carboplatin, Chemotherapy, Infinnium, Letrozole, Medical Oncology, Primary low grade serous adenocarcinoma of ovary, Primary malignant neoplasm of the peritoneum, Reproductive system, carboplatin, letrozole, paclitaxel
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients With Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

A Study to Compare Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian or Primary Peritoneal Cancer

Mina Hanna
Female
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-101134-P01-ALCL
19-009074
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

  • Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up.
  • All women will, by definition, be considered menopausal due to surgical removal of both ovaries prior to trial enrollment.
  • Patients must have newly diagnosed, stage II-IV low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinoma) of the ovary or peritoneum. Tumors must be assessed for nuclear p53 staining.
  • Appropriate stage for study entry based on the following diagnostic workup: 
    • History/physical examination within 14 days prior to registration; 
    • Contrast-enhanced imaging of the chest, abdomen and pelvis within 28 days prior to registration. 
  • Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal (< 1 cm diameter residual disease/nodule) or suboptimal residual disease (> 1 cm diameter residual disease/nodule) status allowed. 
  • Patients must have undergone a bilateral salpingo-oophorectomy. 
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to registration .
  • Patients must be within ≤ 8 weeks of primary cytoreductive surgery prior to initial randomization.
  • Patients must be able to take per oral (P.O.) medications. 
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl (within 14 days prior to registration). 
  • Platelets greater than or equal to 100,000 cells/mcl (within 14 days prior to registration).
  • Creatinine less than or equal to 1.5 x upper limit of normal (ULN) (within 14 days prior to registration).
  • Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible if there is no hydronephrosis and the estimated creatinine clearance (CCr) is >= 30 ml/min (within 14 days prior to registration).
  • Bilirubin less than or equal to 1.5 x ULN (within 14 days prior to registration).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3 x ULN (within 14 days prior to registration).
  • Alkaline phosphatase less than or equal to 2.5 x ULN (within 14 days prior to registration). 
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information.


Exclusion Criteria:
 

  • Patients with concomitant invasive malignancy or a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the past five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol. 
  • Patients may not have received neoadjuvant chemotherapy or radiotherapy for the treatment of this disease. 
  • Patients may not have received previous hormonal therapy for the treatment of this disease. 
  • Patients with known hypersensitivity to letrozole or hypersensitivity/intolerance to carboplatin/paclitaxel therapy. 
  • Patients with severe cardiac disease. 
  • Myocardial infarction or unstable angina within 6 months prior to registration. 
  • New York Heart Association (NYHA) Class II or greater congestive heart failure. 
  • Patients with known central nervous system metastases.
  • Patients with active or uncontrolled systemic infection. 
  • Patients with ≥ Grade 2 baseline neuropathy. 
  • Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration.
  • Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
Drug therapy, Hormone therapy, Drug, Administration of antineoplastic agent, Chemotherapy
Cancer, Ovarian cancer, Peritoneal cancer
Cancer treatment, Carboplatin, Chemotherapy, Infinnium, Letrozole, Medical Oncology, Primary low grade serous adenocarcinoma of ovary, Primary malignant neoplasm of the peritoneum, Reproductive system, carboplatin, letrozole, paclitaxel
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic Health System — Albert Lea, MN

GCAR-7213: GBM AGILE Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM) (GBM AGILE)

A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma

Evanthia Galanis
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-101139-P01-RST
19-008128
Show full eligibility criteria
Hide eligibility criteria

Newly-Diagnosed

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) established following either a surgical resection or biopsy. An MRI scan with the required imaging sequences performed within 21 days prior to randomization preferably. The post-operative MRI scan performed within 96 hours of surgery or the MRI scan performed for radiation therapy planning may serve as the MRI scan performed during screening if all required imaging sequences were obtained.
  • Karnofsky performance status ≥ 60%. performed within a 14-day window prior to randomization.
  • Availability of tumor tissue representative of GBM from definitive surgery or biopsy.

Recurrent

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum radiation therapy (RT).
  • Evidence of recurrent disease demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria.
  • Two scans to confirm progression are required: at least 1 scan at the time of progression and 1 scan prior to the time of progression.
  • Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization.
  • Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed.

Newly-Diagnosed


Exclusion Criteria:

  • Received any prior treatment for glioma including:
    • Prior prolifeprospan 20 with carmustine wafer;
    • Prior intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent;
    • Prior radiation treatment for GBM or lower-grade glioma;
    • Prior chemotherapy or immunotherapy for GBM or lower-grade glioma. Receiving additional, concurrent, active therapy for GBM outside of the trial.
  • Extensive leptomeningeal disease.
  • QTc > 450 msec if male and QTc > 470 msec if female.
  • History of another malignancy in the previous 2 years, with a disease-free interval of < 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.

Recurrent


Exclusion Criteria:

  • Early disease progression prior to 3 months (12 weeks) from the completion of RT.
  • More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of temozolomide (TMZ) with an experimental agent, is considered one line of chemotherapy).
  • Received any prior treatment with lomustine, agents part of any of the experimental arms, and bevacizumab or other vascular endothelial growth factor (VEGF) or VEGF receptor-mediated targeted agent.
  • Any prior treatment with prolifeprospan 20 with carmustine wafer.
  • Any prior treatment with an intracerebral agent.
  • Receiving additional, concurrent, active therapy for GBM outside of the trial.
  • Extensive leptomeningeal disease.
  • QTc > 450 msec if male and QTc > 470 msec if female.
  • History of another malignancy in the previous 2 years, with a disease-free interval of < 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.

Eligibility last updated 2/16/22. Questions regarding updates should be directed to the study team contact.

Drug, Radiation, Administration of antineoplastic agent, Biopsy of brain tissue tumor, Drug therapy, Excision of lesion of brain tissue
Brain tumor, Cancer, Glioblastoma, Glioblastoma multiforme, Glioma, Recurrent cancer
Biological therapy for cancer, Brain tumor surgery, Cancer treatment, Chemotherapy, Glioblastoma multiforme, Gliosarcoma, Medical Oncology, Nervous system, Recurrent malignant neoplastic disease
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

MC1935: A Phase III Trial of Hypofractionated Radiotherapy to the Whole Breast or Post-mastectomy Chest Wall Including Regional Nodal Irradiation

A Study to Evaluate Radiotherapy to the Whole Breast or Post-mastectomy Chest Wall Including Regional Nodal Irradiation

Robert Mutter
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101144-P01-RST
19-008858
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histological confirmation of breast cancer.
  • Breast conserving surgery or mastectomy (reconstruction is allowed).
  • Clinical or pathologic T1-T4c, N0-3, M0 disease.
  • ECOG Performance Status (PS) 0 to 2.
  • Indications for breast or post mastectomy radiation with regional nodal radiotherapy per the discretion of the treating physician.
  • If uncertain of eligibility please consult the PI.


Exclusion Criteria:

  • Medical contraindication to receipt of radiotherapy.
  • Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator or PI, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent.
  • Active systemic lupus or scleroderma.
  • Prior receipt of ipsilateral breast or chest wall radiation.
  • Persistent positive margins on ink after definitive surgery either for DCIS or invasive cancer.
  • No active metastatic disease from other origin.
  • Recurrent breast cancer.
  • Patient requires bilateral breast radiation treatment.
  • cT4d patients (inflammatory breast cancer).
  • Patients that may not be compliant or fit for the study at the discretion of the PI.
  • Male patients.

 

Hypofractionated whole breast radiation therapy, Radiotherapy to chest wall, Radiation
Breast cancer, Cancer
Breast cancer surgery, Cancer treatment, Malignant neoplasm of female breast, Mastectomy, Medical Oncology, Radiation therapy, Radiation therapy for breast cancer, Oncoplastic breast-conserving surgery
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A Phase 1b Open-label, Multicenter Dose Escalation and Expansion Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors (MT-5111)

A Study of MT-5111 in HER2-positive Solid Tumors

Joleen Hubbard
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-101152-P01-RST
19-010052
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Subject must sign the written ICF before any screening procedure.
  • Subject must be aged ≥ 18 years (y) on the date of signing the informed consent.
  • Subject must have histologically confirmed, unresectable, locally advanced or metastatic solid cancers.
    • In Part A, all HER2-positive solid cancers are eligible;
    • In Part B, HER2-positive breast, GEA and other HER2- positive solid cancers are eligible for the respective expansion groups.
  • All subjects in both parts of the study must be HER2-positive in the latest tumor sample tested for HER2 (it is required that testing is done on a metastatic lesion in cases of metastatic cancers for subjects with metastatic disease), according to standard testing procedures. For the purpose of this study, HER2-positivity is defined as:
    • Tumors tested by IHC: must have an IHC status of 2+ or 3+, regardless of ISH result; OR
    • BC or GEA tumors tested by ISH only (no IHC available): must be HER2-positive.
    • Note: cancers other than BC and GEA must be tested via IHC and must have a status of 2+ or 3+, regardless of ISH result.
  • Subject should be relapsed or refractory to existing therapy(ies) known to provide clinical benefit for the underlying cancer or have been intolerant of such therapies.
    • Subjects with HER2-positive BC per American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines (Wolff et al, 2018) should have received at least 2 lines of HER2-directed therapy in the advanced setting and should have received at least 2 of the following: pertuzumab, trastuzumab emtansine, tucatinib or fam trastuzumab deruxtecan in either the early-stage or advanced setting. Subjects with tumors that are HER2 2+ by IHC and without gene amplification are not required to have received prior HER2-targeting therapy;
    • Subjects with HER2-positive gastric cancer per ASCO-CAP guidelines (Bartley et al, 2016) must have previously received trastuzumab or fam trastuzumab deruxtecan or have been intolerant of such therapy. Subjects with tumors that are HER2 2+ by IHC and without gene amplification are not required to have received prior HER2-targeting therapy.
  • Subject must have at least 1 measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (APPENDIX D: Eisenhauer et al, 2009).
    • Subjects with evaluable disease only may be included in the dose escalation phase.
  • Subject must have Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 (APPENDIX B).
  • Subject must have a life expectancy of at least 3 mo. 9. Subject must have adequate bone marrow function, as determined by:
    • ANC ≥ 1,000/mm^3;
    • Platelet count ≥ 75,000 mm³; and
    • Hemoglobin ≥ 8.0 g/dL. Red blood cell transfusion within 2 wk of study treatment start is allowed if hemoglobin levels remain stable (i.e., do not decrease by > 1 g/dL by C1D1).
  • Subject must have adequate kidney function, as determined by: a. Creatinine clearance ≥ 50 ml/min either measured or estimated using the Cockcroft-Gault formula.
  • Subject must have adequate hepatic function, as determined by:
    • Total bilirubin ≤ 1.5 x ULN, or ≤ 3 x ULN for subjects with Gilbert’s Syndrome; and
    • AST ≤ 3 x ULN (or ≤ 5 x ULN if liver metastasis); and
    • ALT ≤ 3 x ULN (or ≤ 5 x ULN if liver metastasis).
  • Subject must have adequate serum albumin, as determined by:
    • Albumin ≥ 2.5 g/dL.
  • Subject must have adequate coagulation, as determined by:
    • international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN; and
    • partial thromboplastin time ≤ 1.5 x ULN.
  • Subject must have adequate cardiac function, as determined by:
    • LVEF ≥ 55% assessed by ECHO (preferred), or multigated acquisition (MUGA) scan; and
    • QTcF ≤ 480 ms for women and QTcF ≤ 450 ms for men (average from 3 QTcF values on the triplicate 12-lead electrocardiogram) at baseline.
    • NOTE: Subjects with right bundle branch block and LVEF ≥ 55% will be eligible for participation.
  • Women of reproductive potential must have a negative pregnancy test during the screening period within 72 h before the start of treatment. Women not of reproductive potential are female subjects who are postmenopausal or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy).
  • Subjects of reproductive potential must agree to either abstain continuously from heterosexual intercourse or to use a highly effective method of birth control between signing the informed consent until 90 d after last study treatment. The Investigator or Delegate should advise the subject to use a double barrier method to achieve adequate contraception. The following birth control methods will be considered as adequate:
    • Condoms (male or female) with a spermicidal agent;
    • Diaphragm or cervical cap with spermicide;
    • Condom with diaphragm;
    • Intrauterine device;
    • Hormone-based contraception: Established use of oral, injected, or implanted hormonal methods of contraception;
    • Vasectomy (for a male subject or male partner of a female subject).


Exclusion Criteria:
 

  • History or current evidence of neoplastic disease that is histologically distinct from the tumor under study, except cervical carcinoma in situ, superficial noninvasive bladder tumors, curatively treated Stage I-II non-melanoma skin cancer, or any other previous cancer curatively treated less than 2 y prior to enrollment in this study. Subjects with any other active malignancy may only be enrolled after discussion and approval by the Sponsor.
  • Current evidence of new or growing central nervous system (CNS) metastases during screening. Subjects with known CNS metastases will be eligible if they meet all the following criteria:
    • Had radiotherapy or another appropriate therapy for the CNS metastases;
    • Have no neurological symptoms > Grade 2, with approval by the Medical Monitor;
    • Have stable CNS disease on the Computed tomography (CT) or magnetic resonance imaging (MRI) scan within 4 wk before signing the informed consent compared with prior neuro-imaging;
    • Do not require steroid therapy.
  • Current evidence of CTCAE Grade > 1 toxicity before the start of treatment, except for hair loss and those Grade 2 toxicities listed as permitted in other eligibility criteria. Subjects with Grade 2 neurologic symptoms or other toxicities that are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor.
  • Current evidence of incomplete recovery from surgery or radiotherapy at screening, or planned surgery or radiotherapy from the start of treatment until the STFU Visit, except minor elective surgery deemed acceptable by the Investigator.
  • History or current evidence of significant (CTCAE Grade ≥ 2) infection or wound within 2 wk before the start of treatment.
  • history or current evidence of significant cardiovascular disease before the start of treatment, but not limited to the following conditions:
    • High sensitivity troponin I or T > ULN at screening;
    • Angina pectoris requiring anti-anginal medication, (chest pain: CTCAE Grade ≥ 2) or clinically significant valvular disease;
    • Myocardial infarction within 12 mo prior to the start of treatment;
    • Arterial thrombosis or pulmonary embolism within ≤ 6 mo before the start of treatment;
    • Pericarditis (any CTCAE grade), pericardial effusion (CTCAE Grade ≥ 2), non-malignant pleural effusion (CTCAE Grade ≥ 2) or malignant pleural effusion (CTCAE Grade ≥ 3) (subjects with pleural effusion that is manageable and stable > 3 mo prior to study are eligible);
    • Left bundle branch block;
    • History of Grade ≥ 2 symptomatic congestive heart failure or New York Heart Association (NYHA): Class ≥ II;
    • High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia [CTCAE Grade ≥ 2] [ventricular tachycardia], or higher-grade atrioventricular [AV]-block [second degree AV-block Type 2 (Mobitz 2) or third degree AV-block]).
  • Current evidence of active, uncontrolled hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) (evidenced by detectable viral load by polymerase chain reaction or acquired immunodeficiency syndrome (AIDS) related illness.
    • Serology and virology measurements are not required to be performed at screening, but any previously-reported results should be used for eligibility purposes. Subjects with no previously reported results are eligible in the absence of history of HBV/HCV/HIV. Investigators will test per their discretion;
    • Subjects with a history of treated hepatitis C and non-quantifiable HCV-ribonucleic acid may be enrolled;
    • Subjects on treatment for HBV and/or HIV will be eligible if they have undetectable viral load.
    • Subjects with CD4+ T-cell (CD4+) counts ≥ 350 cells/µL may be enrolled;
    • Subjects taking atazanavir should be considered for alternate therapy given the risk of cardiac conduction abnormalities.
  • Known or suspected hypersensitivity to the study drug or excipients contained in the study drug formulation.
  • Current evidence of hypersensitivity requiring systemic steroids at doses > 20 mg/d prednisone equivalent.
  • History or current evidence of any other medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the Investigator, will increase the risks associated with study participation, or require treatments that will interfere with the conduct of the study or the interpretation of study results.
  • Current evidence of ≥ Grade 2 underlying pulmonary disease.
  • Women who are pregnant or breastfeeding.
  • Subjects with unintentional weight loss greater than 10% of their body weight over the preceding 3 mo or less.
  • Therapeutic anticoagulation for a thromboembolic event within 2 wk before the start of treatment (prophylactic anticoagulation is allowed).
  • Received systemic therapy for the cancer under study or any investigational drug within 4 wk before the start of treatment.
  • Received immunosuppressive agents or other prescribed corticosteroids at doses ≥ 20 mg prednisone equivalent per d within 2 wk before the start of treatment.
  • For Part A (dose escalation phase): Received chemotherapy with doxorubicin (or another anthracycline) at any time. For Part B (dose expansion phase): Received chemotherapy with anthracycline or anthracenedione agents at the doxorubicin equivalent cumulative dose (sum total for all agents combined) of 550 mg/m^2 body surface area, or a lower total doxorubicin equivalent cumulative dose that, in the opinion of the Investigator, would increase the risk of cardiomyopathy in this study, or subjects who have received mitoxantrone at cumulative doses considered to increase the risk of cardiomyopathy. For subjects who have received a cumulative dose of an anthracycline of more than 300 mg/m^2 , approval must first be obtained from the Medical Monitor.
  • Received granulocyte colony–stimulating factor or granulocyte-macrophage colony–stimulating factor for the treatment of leukopenia within 2 wk before the start of treatment.

Eligibility last updated 8/11/21. Questions regarding updates should be directed to the study team contact.

Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

MC1974: A Study of Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration In HPV Head And Neck Cancer Of Unknown Primaries (HNCUP)

A Study to Evaluate Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration In HPV Head And Neck Cancer

Daniel Ma
All
18 years and over
Early Phase 1
This study is NOT accepting healthy volunteers
0000-101161-P01-RST
19-012222
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Patients meet criteria for IMPT treatment for Oropharyngeal Cancer as outlined in the procedure manual.
  • If IMPT is declined by patient’s insurance, they can be treated with standard of care IMRT using the same applicable standard of care procedures outlined in the procedures manual.
  • Meet criteria for adjuvant chemotherapy (if applicable).
  • Histological confirmation of HPV+ squamous cell carcinoma as defined by neck node pathology. HPV positivity will be defined as positive staining for p16 and HPV DNA ISH. (If discordant, RNA ISH will be run for confirmatory testing).
  • Clinical stage T0 N1-N3 and confirmed Pathologic stage T0 N1-N2 M0 (AJCC 8th edition) with one of the following risk factors:
    • lymph node ≥ 3cm;
    • ≥ positive lymph nodes;
    • presence of extracapsular extension;
    • > 1 nodal level involved.
  • Absence of distant metastases on standard diagnostic workup, prior to registration (Chest CT, CXR, or PET/CT).
  • Able to undergo pre-operative Q-clear series PET/CT head/neck for diagnostic workup of occult primary and nodal disease.
  • Able to undergo Transoral Surgery and neck dissection by their ENT oncologist.
  • Surgical exploration/sampling of all mucosal sites including ipsilateral wide field tonsillectomy and base of tongue resection.  Additional biopsies or surgical excision at the surgeon’s discretion. Any radiographic or clinically suspicious areas should be biopsied or removed. Bilateral neck dissection for high risk patients. Ipsilateral dissection only, for patients with contralateral cN0 necks and negative preoperative imaging.
  • Final pathologic evaluation demonstrating all benign samplings without discernible primary.
  • Documented smoking history.
  • ECOG Performance Status (PS) 0 or 1. 
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
  • Following laboratory values obtained ≤ 35 days prior to registration:
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
    • Platelet count ≥100,000/mm^3;
    • Hemoglobin  ≥8.0g/dL;
    • Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min;
    • Total or direct bilirubin < 2 x institutional upper limit of normal (ULN);
    • AST (SGOT) or ALT (SGPT) < 3 x institutional ULN.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Able to provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).

 


Exclusion Criteria:

 

  • Any patient with positive retropharyngeal nodes on imaging.
  • 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.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Other active malignancy ≤ 5 years prior to registration.
    • EXCEPTIONS: Non-melanotic skin cancer, breast cancer, prostate cancer, well-differentiated thyroid cancer, carcinoma-in-situ of the cervix.
    • NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer.
  • Immunocompromised patients and patients known to be HIV positive.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • History of connective tissue disorders such as scleroderma, rheumatoid arthritis, lupus, or Sjogren’s disease.
  • Prior history of radiation therapy to the affected site.
Radiation
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

ION-682884-CS3 A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

NEURO-TTRansform: A Study to Evaluate the Efficacy and Safety of AKCEA-TTR-LRx in Participants With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

Morie Gertz
All
18 years to 82 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-101170-P01-RST
19-011570
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. Aged 18 to 82 years at the time of informed consent 2. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal or abstinent 3. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the subject or the subject''s non-pregnant female partner must be using a highly effective contraceptive method 4. Diagnosis of hereditary transthyretin-mediated polyneuropathy as defined by meeting all 3 of the following:
• Stage 1 or Stage 2 Familial Amyloid Polyneuropathy (FAP) or Coutinho Stage
• Documented genetic mutation in the TTR gene
• Symptoms and signs consistent with neuropathy associated with transthyretin amyloidosis, including NIS ≥ 10 and ≤ 130
Exclusion Criteria:
1. Clinically-significant (CS) abnormalities in medical history, screening laboratory results, physical or physical examination that would render a subject unsuitable for inclusion, including but not limited to abnormal safety labs 2. Karnofsky performance status ≤ 50 3. Other causes of sensorimotor or autonomic neuropathy (e.g., autoimmune disease), including uncontrolled diabetes 4. Prior liver transplant or anticipated liver transplant within 1-yr of Screening 5. New York Heart Association (NYHA) functional classification of ≥ 3 6. Acute coronary syndrome within 6 months of screening or major surgery within 3 months of Screening 7. Other types of amyloidosis 8. Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study 9. Current treatment with any approved drug for hereditary TTR amyloidosis such as Vyndaqel® / Vyndamax™ (tafamidis), Tegsedi™ (inotersen), Onpattro™ (patisiran), off-label use of diflunisal or doxycycline, and tauroursodeoxycholic acid (TUDCA). If previously treated with Vyndaqel® / Vyndamax™, diflunisal or doxycycline, and TUDCA, must have discontinued treatment for at least 2 weeks prior to Study Day 1 10. Previous treatment with Tegsedi™ (Inotersen) or Onpattro™ (patisiran), or other oligonucleotide or RNA therapeutic (including siRNA)
Drug therapy, Drug
Amyloidosis, Neuropathies, Polyneuropathy
Eplontersen [USAN], Hematopoietic system, Inotersen [USAN], Polyneuropathy in amyloidosis, Transthyretin related familial amyloid cardiomyopathy, inotersen
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

KT-US-471-0119, A Phase 1/2 Open-label, Multicenter Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects with Relapsed or Refractory Large B-cell Lymphoma (ZUMA-19)

Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects with Relapsed or Refractory Large B-cell Lymphoma

Saad Kenderian
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-101173-P01-RST
19-012798
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Adult subjects with large B-cell lymphoma, including Diffuse large B-cell lymphoma (DLBCL) not otherwise specified, Primary mediastinal large B-cell lymphoma (PMBCL), High-grade B-cell lymphoma (HGBL), and Diffuse large B-cell lymphoma (DLBCL) arising from Follicular lymphoma (FL).
  • Subjects must have relapsed disease after 2 or more lines of systemic therapy, OR chemorefractory disease defined as the following: No response to first-line therapy, including the following: PD as best response to first therapy, SD as best response after ≥ 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP), with SD duration no longer than 6 months from the last dose of therapy, Note: Subjects who are intolerant to first-line chemotherapy are excluded OR No response to ≥ 2 lines of therapy, including the following: PD as best response to most recent therapy, SD as best response after ≥ 2 cycles of last line of therapy.
  • Subjects must have received adequate prior therapy including at a minimum: Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and An anthracycline-containing chemotherapy regimen, Subjects with transformed FL must have chemorefractory disease after transformation to DLBCL.
  • At least 1 measurable lesion according to the International Working Group (IWG) Lugano Classification {Cheson 2014}. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
  • Magnetic resonance imaging of the brain showing no evidence of CNS lymphoma.
  • At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy. At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists).
  • Toxicities due to prior therapy must be stable and recovered to Grade ≤ 1 (except for clinically nonsignificant toxicities such as alopecia).
  • Age 18 or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Additional Inclusion Criteria may apply.


Exclusion Criteria:

  • History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) or FL unless disease free for at least 3 years.
  • History of Richter’s transformation of chronic lymphocytic leukemia.
  • Autologous stem cell transplant (SCT) within 6 weeks of planned axicabtagene ciloleucel infusion.
  • History of allogeneic stem cell transplantation.
  • Prior CD19 targeted therapy or prior CAR T cell therapy.
  • History of PAP.
  • History of severe, immediate hypersensitivity reaction attributed to aminoglycosides.
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite medical monitor.
  • Known history of human immunodeficiency virus (HIV) infection, hepatitis B (HBsAg positive) or hepatitis C (anti-HCV positive) infection. A history of hepatitis B or hepatitis C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.
  • Additional Exclusion Criteria may apply.
Biologic/Vaccine, Drug
I'm interested
Share via email

ME-522-001: A Phase 1, Open-label, Study of Voruciclib in Subjects with Relapsed and/or Refractory B-Cell Malignancies or Acute Myeloid Leukemia After Failure of Prior Standard Therapies and Voruciclib in Combination with Venetoclax in Subjects with Relapsed and/or Refractory Acute Myeloid Leukemia

A Phase 1 Study of Voruciclib in Subjects With B-Cell Malignancies or AML

Kebede Begna
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-101182-P01-RST
19-010929
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Age ≥18 years

- Histologically-confirmed diagnosis of Follicular lymphoma (FL), mantle cell lymphoma
(MCL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), chronic
lymphocytic leukemia(CLL), diffuse large B-cell lymphoma (DLBCL), or AML

a. Subjects must have disease that has relapsed or is refractory to 2 or more prior
regimens and in need of treatment due to progressive disease

- Presence of measurable disease defined per the 2008 International workshop on CLL
guidelines, or by 2014 Lugano criteria for non-Hodgkin lymphoma (does not apply for
AML subjects)

- Adequate hematologic parameters unless clearly due to the disease under study

- Adequate renal and hepatic function, per laboratory reference range at screening


Exclusion Criteria:


- History of pneumonitis of any cause

- For CLL subjects: only known histological transformation to an aggressive lymphoma

- For AML subjects:

1. Acute promyelocytic leukemia

2. Peripheral blast count > 25 × 10 9/L

- Known central nervous system involvement

- Significant cardiovascular disease

- Significant screening ECG abnormalities

- Subjects who require warfarin, anti-cancer therapeutics or investigational agents

- Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper
respiratory tract infections) at the time of start of voruciclib therapy

- Prior solid organ transplantation

- Receipt of an allogeneic transplant within 6 months or an autologous transplant within
the preceding 3 months; evidence of ongoing graft-versus-host disease (GVHD)

- Prior therapy with a cyclin-dependent kinase (CDK9) inhibitor

- Symptomatic/uncontrolled HIV infection/AIDS, or currently taking contraindicated
medications for HIV control

- Ongoing immunosuppressive treatment including calcineurin inhibitors at the time of
the start of study treatment, including systemic or enteric corticosteroids except as
follows:

1. Prior to the start of study treatment, subjects may be using systemic
corticosteroids (≤20 mg/day of prednisone or equivalent), topical, or inhaled
corticosteroids

2. During study therapy, subjects may use systemic, topical, or enteric
corticosteroids, if needed

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/6/22. Questions regarding updates should be directed to the study team contact.

Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

ADVL1823, Larotrectinib (LOXO-101, NSC# 788607) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias (ADVL1823)

A Study to Evaluate Larotrectinib to Treat Patients with Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute Leukemia

Carola Arndt
All
up to 30 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-101183-P01-RST
19-010273
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

  • Patients must be ≤ 30 years of age at the time of study entry.

COHORT A

  • Patients must have a histologic diagnosis of infantile fibrosarcoma with an NTRK1, NTRK2, or NTRK3 fusion identified in a Clinical Laboratory Improvement Amendments/College of American Pathologists (CLIA/CAP) certified laboratory. Fusions may be identified by fluorescence in situ hybridization (FISH) or molecular techniques (reverse transcriptase-polymerase chain reaction [RT-PCR] using primers flanking the fusion junction or next generation sequencing). For fusions identified by FISH, an ETV6 rearrangement is sufficient for eligibility in Cohort A. Identification of the upstream TRK fusion partner is not required. 

COHORT B

  • Patients must have a histologic diagnosis of any solid tumor other than infantile fibrosarcoma, including central nervous system (CNS) tumors but excluding high grade gliomas. An NTRK1, NTRK2, or NTRK3 fusion must be identified in a CLIA/CAP certified laboratory. Fusions may be identified by FISH or molecular techniques (RT-PCR using primers flanking the fusion junction or next generation sequencing). For fusions identified by FISH, there must be an identified rearrangement in NTRK1, NTRK2, or NTRK3 (e.g., an ETV6 rearrangement is not sufficient for eligibility) unless the patient has a diagnosis of congenital mesoblastic nephroma in which case an ETV6 rearrangement is sufficient for eligibility. Identification of the upstream TRK fusion partner is not required. 

COHORT C

  • Patients must have a histologic diagnosis of relapsed or refractory acute leukemia with an NTRK1, NTRK2, or NTRK3 fusion identified in a CLIA/CAP certified laboratory. Fusions may be identified by FISH or molecular techniques (RT-PCR using primers flanking the fusion junction or next generation sequencing). For fusions identified by FISH, there must be an identified rearrangement in NTRK1, NTRK2, or NTRK3 (e.g., an ETV6 rearrangement is not sufficient for eligibility). Identification of the upstream TRK fusion partner is not required.

SOLID TUMORS (COHORTS A AND B)

  • Patients must have measurable disease. Patients must have disease that cannot be completely resected without a predicted functional, neurologic, or significant cosmetic deficit in the opinion of the investigator. 

LEUKEMIA (COHORT C)

  • Patients must have ≥ 5% blasts in the bone marrow. Extramedullary disease is permitted. 
  • Patients must have a Lansky or Karnofsky performance status score of ≥ 50, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
    • Note: Neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. 

COHORTS A AND B

  • No prior anti-cancer therapy, including radiotherapy, other than surgical resection is permitted.
  • Patients who experience recurrence after surgery alone and no other anti-cancer therapy will be eligible.
  • If not eligible due to prior anticancer therapy, patients may be eligible for the larotrectinib arm of Pediatric MATCH (APEC1621A) or treatment with commercial larotrectinib off study. 

COHORT C

  • Patients with relapsed leukemia (Cohort C) must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met; e.g., blood count criteria, the patient is considered to have recovered adequately. 
  • Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment. 
  • A waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e., corticosteroid, vincristine, thioguanine [6MP], and/or methotrexate). 
  • A waiting period is not required for patients receiving a single dose of intrathecal methotrexate, hydrocortisone, and/or cytarabine within 7 days prior to enrollment.
  • ≥ 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy. Additionally, patients must have fully recovered from all acute toxic effects of prior therapy. 
    • Note: Cytoreduction with hydroxyurea must be discontinued ≥ 24 hours prior to the start of protocol therapy. 
    • Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil [ANC] counts): ≥ 7 days after the last dose of agent. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment. 
    • Antibodies: ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade ≤ 1. There is an exception for blinatumomab infusions, for which patients must have been off for at least 3 days and all drug related toxicity must have resolved to grade 2 or lower as outlined in the inclusion/exclusion criteria. 
    • Corticosteroids: If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid. A waiting period prior to enrollment is not required for patients receiving corticosteroid for leukemia therapy/cytoreduction. 
    • Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator.
      •Interleukins, interferons and cytokines (other than hematopoietic growth factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors ).
    • Stem cell infusions (with or without total body irradiation [TBI]): 
    • Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: ≥ 84 days after infusion and no evidence of graft versus host disease (GVHD). 
    • Autologous stem cell infusion including boost infusion: ≥ 42 days. 
    • Cellular therapy: ≥ 42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer [NK] cells, dendritic cells, etc.) 
    • Radiation therapy (XRT)/external beam irradiation including protons: ≥ 14 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis; ≥ 42 days if other substantial BM radiation. 
    • Radiopharmaceutical therapy (e.g., radiolabeled antibody): ≥ 42 days after systemically administered radiopharmaceutical therapy. 
    • Patients must not have received prior exposure to TRK inhibitors (including larotrectinib, LOXO-195, entrectinib, lorlatinib, crizotinib, or lestaurtinib). 
    • For patients with solid tumors without known bone marrow involvement: 
      • Peripheral absolute neutrophil count (ANC) ≥ 1000/mm^3 (within 7 days prior to enrollment);
      • Platelet count ≥ 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment);
      • Hemoglobin ≥ 8.0 g/dL at baseline (may receive red blood cell [RBC] transfusions).
    • Patients with solid tumors with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. 
    • For patients with leukemia: 
      • Platelet count ≥ 20,000/mm^3 (may receive platelet transfusions) (within 7 days prior to enrollment); 
      • Hemoglobin ≥ 8.0 g/dL at baseline (may receive RBC transfusions).
    • These patients must not be known to be refractory to red cell or platelet transfusion. 
    • Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment): 
      • 1 month to < 6 months (male 0.4 mg/dL, female 0.4 mg/dL);
      • 6 months to < 1 year (male 0.5 mg/dL, female 0.5 mg/dL);
      • 1 to < 2 years (male 0.6 mg/dL, female 0.6 mg/dL);
      • 2 to < 6 years (male 0.8 mg/dL, female 0.8 mg/dL);
      • 6 to < 10 years (male 1 mg/dL, female 1 mg/dL); 
      • 10 to < 13 years (male 1.2 mg/dL, female 1.2 mg/dL); 
      • 13 to < 16 years (male 1.5 mg/dL, female 1.4 mg/dL);
      • ≥ 16 years (male 1.7 mg/dL, female 1.4 mg/dL);
      • For patients < 1 month of age, serum creatinine levels must be < 1.5 x the treating institution's creatinine upper limit of normal (ULN) for patients < 1 month of age or the creatinine clearance or radioisotope GFR must be > 70 mL/min/1.73 m^2. 
    • Patients with solid tumors: 
      • Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age. After approval of the study chair or designee, infants with a higher total bilirubin due to physiologic or breast milk jaundice are eligible if the conjugated (direct) bilirubin is ≤ 2 mg/dL (within 7 days prior to enrollment). 
      • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) ≤ 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L (within 7 days prior to enrollment). 
      • Serum albumin ≥ 2 g/dL (within 7 days prior to enrollment). 
    • Patients with leukemias: 
      • Conjugated (direct) bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment).
      • SGPT (ALT) ≤ 225 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L (within 7 days prior to enrollment).
      • Serum albumin ≥ 2 g/dL (within 7 days prior to enrollment). 
    • Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled. 
    • Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5) except tendon reflex decreased resulting from prior therapy must be ≤ grade 2.


Exclusion Criteria:
 

  • Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies, OR because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Patients of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study therapy. This criterion does not exclude infants who are breast fed. 
  • Patients with solid tumors, including CNS tumors, requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. Patients with leukemia may receive systemic corticosteroids for cytoreduction up to 24 hours prior to the start of protocol therapy. If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid. 
  • Patients who are currently receiving another investigational drug are not eligible.
  • Patients who are currently receiving other anti-cancer agents are not eligible [except leukemia patients receiving corticosteroids or hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy].
  • Patients with leukemia should receive a single dose of intrathecal cytarabine, hydrocortisone, and/or methotrexate within 7 days prior to Day 1 of Cycle 1 at the time of the baseline lumbar puncture. 
  • Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial. 
  • Patients currently receiving a strong CYP3A4 inducer or inhibitor are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study.
    • Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed.
  • Patients with malabsorption syndrome or other conditions that significantly limit enteral absorption are not eligible. 
  • Patients who are unable to swallow capsules or liquid and do not have gastric access via a nasogastric or gastrostomy tube are not eligible. 
  • Patients who have an uncontrolled infection are not eligible. 
  • Patients who have received prior solid organ transplantation are not eligible. 
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
  • Patients with high grade gliomas (HGG) are not eligible.
Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Leukemia
Acute leukemia, Cancer treatment, Hematopoietic system, Larotrectinib [USAN:INN], Medical Oncology, Solid neoplasm with neurotrophic receptor tyrosine kinase gene fusion, Targeted drug therapy, larotrectinib
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

MS200647_0055: A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) as First-line Treatment of Biliary Tract Cancer

Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L Biliary Tract Cancer (BTC)

Amit Mahipal
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-101188-P01-RST
19-012227
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Are ≥ 18 (or ≥ 20 in Japan and Taiwan or age legally considered to be an adult) years of age at the time of signing the informed consent. In Japan, a participant aged < 20 years of age but ≥ 18 years of age may participate if written informed consent from his/her parent or guardian is provided in addition to the participant’s written informed consent.
  • Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC, including intrahepatic CCA, extrahepatic CCA, gallbladder cancer, and ampulla of Vater’s cancer. The histological origin of ampullary carcinomas (intestinal, pancreaticobiliary, or other) will be collected.
  • Naïve to chemotherapy, immunotherapy, and interventional radiological treatment (transarterial chemo-embolization, transarterial embolization, transarterial infusion) for locally advanced or metastatic BTC. Participants whose disease has recurred ≥ 6 months after completion of neoadjuvant or adjuvant treatments will be considered eligible.
  • Availability of tumor tissue (primary or metastatic) (fresh or archival biopsies) before the first administration of study intervention. Availability of tumor tissue is mandatory except for the safety run-in part. Brush cytology and cell blocks are not acceptable. Tumor tissue (fresh or archival) must be suitable for biomarker assessment as described in the Laboratory Manual.
  • At least 1 measurable lesion according to RECIST 1.1. Participants in the safety run-in part do not require a measurable lesion at baseline.
  • ECOG PS of 0 or 1 at study entry and at Week 1, Day 1 prior to dosing.
  • Life expectancy of ≥ 12 weeks, as judged by the Investigator.
  •  Adequate hematological function defined by white blood cell count ≥ 2.0 × 10^9 /L with absolute neutrophil count ≥ 1.5 × 10^9 /L, lymphocyte count ≥ 0.5 × 10^9 /L, platelet count ≥ 100 × 10^9 /L, and hemoglobin (Hgb) ≥ 9 g/dL (participants may have been transfused) at study entry and at Week 1 Day 1 prior to dosing.
    • Previously transfused participants are allowed in the study with a stable Hgb of ≥ 9 g/dL at the time of study entry.
  • Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × upper limit of normal (ULN), an aspartate aminotransferase level ≤ 3.0 × ULN, and an alanine aminotransferase level ≤ 3.0 × ULN. For participants with liver involvement, aspartate aminotransferase ≤ 5.0 × ULN and alanine aminotransferase ≤ 5.0 × ULN are acceptable.
  • Adequate renal function defined by an estimated creatinine clearance (CrCl) > 50 mL/min according to the Cockcroft-Gault formula or by measure of CrCl from 24-hour urine collection.
    • CrCl (mL/min) = (140-age) × weight (kg) / (72 × serum creatinine Cr[jaffe]);
    • If female, × 0.85 ;
    • If creatinine is measured by the enzymatic method, add 0.2 and use as Cr[jaffe] = 0.2 + Cr[enzyme].
  • Albumin ≥ 2.8 g/dL.
  • Adequate coagulation function defined as prothrombin time or international normalized ratio ≤ 1.5 × ULN unless the participant is receiving anticoagulant therapy.
  • Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals (e.g., entecavir, tenofovir, or lamivudine; adefovir or interferon is not allowed) at study entry and with planned monitoring and management including baseline HBV DNA quantity according to appropriate labeling guidance. Participants receiving active hepatitis C virus (HCV) therapy must be on a stable dose at study entry and with planned monitoring and management according to appropriate labeling guidance of approved antiviral.
  • Are male or female:
    • Male Participants Agree to the following during the intervention period and for at least 4 months after the last dose of study intervention (35 days corresponding to the time needed to eliminate any study interventions; e.g., 5 terminal half-lives plus 90 days for spermatogenic cycle):
      • Refrain from donating sperm PLUS, either:  Abstain from any activity that allows for exposure to ejaculate; OR
      • Use a male condom:  When having sexual intercourse with a woman of childbearing potential who is not currently pregnant, and advise her to use a highly effective contraceptive method with a failure rate of < 1% per year since a condom may break or leak;
      • When engaging in any activity that allows for exposure to ejaculate.
    • Female participants are not pregnant or breastfeeding and at least 1 of the following conditions applies: Not a woman of childbearing potential; OR
    • If a woman of childbearing potential, agree to use a highly effective contraceptive method (i.e., with a failure rate of < 1% per year), preferably with low user dependency for the following time periods: 
      Before the first dose of study intervention(s), if using hormonal contraception:
      • Has completed at least one 4-week cycle of an oral contraceptive pill and has either had or has begun her menses; OR
      • Has used a depot contraceptive or extended-cycle contraceptive for at least 28 days and has a documented negative pregnancy test using a highly sensitive assay;
      • During the intervention period;
      • After the study intervention period (i.e., after the last dose of study intervention is administered) for at least 65 days (time needed to eliminate any study interventions, eg, 5 terminal half-lives plus 30 days for a menstrual cycle), and as indicated in the respective label (Summary of Product Characteristics [SmPC]) for gemcitabine and cisplatin. Participants have to agree to the following:
        • Women of childbearing potential should refrain from donating eggs from the start of dosing until 2 months after discontinuing study intervention.
        • The Investigator evaluates the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
      • Have a negative serum or highly sensitive urine pregnancy test, as required by local regulations, within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
      • The Investigator reviews the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a female with an early, undetected pregnancy.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.


Exclusion Criteria:

  • Previous and/or intercurrent cancers. With the exception of: curatively-treated cancers with no recurrence in > 3 years or early cancers treated with curative intent, including but not limited to cervical carcinoma in situ, superficial, noninvasive bladder cancer, basal cell carcinoma, squamous cell carcinoma in situ, or endoscopically resected gastrointestinal cancers limited in mucosal layer.
  • Rapid clinical deterioration not related to malignancy which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or study procedures at study entry and at Week 1 Day 1 prior to dosing.
  • Participants with symptomatic central nervous system (CNS) metastases are excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they are judged to have fully recovered from treatment.
  • Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant).
  • Significant acute or chronic infections including:
    • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (testing at Screening is not required). If an Investigator has a strong suspicion of HIV infection without known history for a participant in screening, but the participant refuses testing, discuss with Medical Monitor to assess eligibility.
      • Note: HIV testing is not mandated for study inclusion; however, if it is performed at any point in screening or while on study, a site must consent the participant for HIV testing as per local standard guidance.
      • Active tuberculosis (presence of clinical symptoms, physical or radiographic findings of active tuberculosis).
      • Uncontrolled biliary infection. Biliary tract obstruction should be released by stenting or percutaneous transhepatic biliary drainage (PTBD). Participants with biliary obstruction should have adequate biliary drainage with no evidence of ongoing infection without antibiotics treatment at the time of enrollment as well as on Cycle 1 Day 1.
      • Active bacterial, fungal, or viral infection (with the exception of hepatitis B and hepatitis C) requiring systemic therapy at study entry and at Week 1 prior to dosing.
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
    • Participants with type 1 diabetes, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible. 
    • Participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg of prednisone or equivalent per day.
    • Administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intra-ocular, or inhalation) is acceptable.
  • History of, or concurrent, interstitial lung disease.
  • Known history of hypersensitivity reactions to bintrafusp alfa or its products or known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0), any history of anaphylaxis, or recent (within 5 months) history of uncontrolled asthma.
  • Clinically significant cardiovascular/cerebrovascular disease as follows: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification ≥ Class II), or serious cardiac arrhythmia.
  • Other severe, acute, or chronic medical conditions, including immune colitis, inflammatory bowel disease, immune pneumonitis, or psychiatric conditions, including recent (within the past year) or active suicidal ideation or behavior. Participants with history of bleeding diathesis or recent major bleeding events considered by the Investigator as high risk for study intervention are also excluded.
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization.
  • Participants who are candidates for liver transplantation and who can receive the transplantation within a medically acceptable period.
  • Concurrent treatment with nonpermitted drugs. Participants who have completed prior adjuvant therapy > 6 months prior to randomization are eligible.
  • Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints), including but not limited to anti-PD-1, anti-PD-L1, anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibody, or anti-4-1BB antibody is not allowed, inclusive of localized administration of such agents.
  • Prior therapy with any antibody/drug targeting TGFβ/TGFβ receptor.
  • Radiation within 28 days other than focal palliative bone-directed radiotherapy.
  • Systemic therapy with immunosuppressive agents within 7 days before the start of study intervention; or use of any investigational drug within 28 days before the start of study intervention.
  • Live vaccine administration within 4 weeks of study intervention administration.
  • Unable to tolerate CT or magnetic resonance imaging (MRI) in the opinion of the Investigator and/or allergy to contrast material.

Other Exclusions:

  • Major surgery within 28 days before the start of study intervention (excluding prior diagnostic biopsy and stenting/PTBD for the purpose of releasing biliary tract obstruction).
  • Pregnancy or breastfeeding.
  • Known alcohol or drug abuse.
  • Legal incapacity or limited legal capacity.
Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Ampullary cancer, Cancer, Cholangiocarcinoma, Gallbladder cancer
1,2-Diaminocyclohexaneplatinum II citrate, Bintrafusp alfa, Biological therapy for cancer, Cancer treatment, Chemotherapy, Digestive system, Gemcitabine [USAN:INN:BAN], Medical Oncology, Primary cholangiocarcinoma of intrahepatic biliary tract, Primary malignant neoplasm of ampulla of Vater, Primary malignant neoplasm of extrahepatic bile duct, Primary malignant neoplasm of gallbladder, Secondary malignant neoplasm of biliary tract, cisplatin, gemcitabine
I'm interested
Share via email

2015LS095: Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women With Advanced Non-Small Cell Lung Cancer

A Study to Evaluate Exemestane in Post-Menopausal Women with Non-Small Cell Lung Cancer (NSCLC)

Mina Hanna
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101198-P01-ALCL
19-008976
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Recurrent or progressive advanced stage non-small cell lung cancer (no small cell component) with most recent treatment being an FDA approved immune checkpoint inhibitor (pembrolizumab, atezolizumab, or nivolumab).
    • NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed to confirm outside diagnosis.
  • Sufficient tumor tissue available from original diagnosis or subsequent biopsy for analysis of estrogen receptor and aromatase.
  • Tumor block or a minimum of 5 unstained slides.
  • Failed at least 1 prior FDA approved treatment for advanced NSCLC. 
  • Measureable disease by RECIST version 1.1.
  • Post-menopausal defined as:
    • Age ≥ 55 years and 1 year or more of amenorrhea;
    •  Age < 55 years and 1 year or more of amenorrhea with an estradiol assay < 20 pg/mL;
    • Surgical menopause with bilateral oophorectomy.
  • ECOG performance status 0, 1 or 2.
  • Life expectancy of 3 months or more in the opinion of the enrolling investigator and documented in the medical record. 
  • Adequate organ function within 14 days of study enrollment defined as: 
  • Hematology:
    • Absolute neutrophil count (ANC) ≥ 1500/mm³;
    • Platelets ≥ 100,000/mm³;
    • Hemoglobin ≥ 8 g/dL.
  • Biochemistry: 
    • Total Bilirubin within normal institutional limits.
    • AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN), except if there is known hepatic metastasis, wherein transaminases may be ≤ 5 x institutional ULN.
    • Serum creatinine ≤ 1.5 mg/dl or glomerular filtration rate > 50 ml/min.
  • Must have recovered to CTCAE v 4 Grade 1 or better from the acute effects of any prior surgery, chemotherapy or radiation therapy. Chronic residual toxicity (i.e., peripheral neuropathy) is permitted. 
  • A minimum time period must elapse between the end of a previous treatment and start of study therapy: 
    • 1 week from the completion of radiation therapy for brain metastases;
    • 4 weeks from the completion of chemotherapy or any experimental therapy;
    • 4 weeks from prior major surgery (such as open biopsy or significant traumatic injury).
  • Voluntary written consent before any research related procedures or therapy.


Exclusion Criteria:

  • Known active CNS disease.
  • If patient has history of brain metastases, the brain lesions must have been treated with radiation and/or surgery.
  • Patients should be neurologically stable and requiring ≤ 10mg oral prednisone equivalence of steroids per day.
  • Any toxicity from immune-related toxicity from prior immune therapy that would preclude further treatment with anti-PD-1/PDL-1 inhibitor or ongoing IR toxicity ≥ Grade 2.
  • Requiring > 10 mg prednisone equivalence of steroids per day for immune-related toxicity.
  • Inability or unwilling to swallow study drug.
  • Any gastrointestinal condition causing malabsorption or obstruction (e.g., celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome).
  • Currently using hormone replacement therapy (oral or patch) or/and phytoestrogen supplements (i.e., black cohosh).
  • Known hypersensitivity to exemestane or its excipients.
  • Any serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatment.
  • Prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free interval.
  • Concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort as these may significantly reduce the availability of exemestane.
Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic Health System — Albert Lea, MN

2015LS095: Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women With Advanced Non-Small Cell Lung Cancer

A Study to Evaluate Exemestane in Post-Menopausal Women with Non-Small Cell Lung Cancer (NSCLC)

Stephan Thome
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101198-P01-MAIJ
19-008976
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Recurrent or progressive advanced stage non-small cell lung cancer (no small cell component) with most recent treatment being an FDA approved immune checkpoint inhibitor (pembrolizumab, atezolizumab, or nivolumab).
    • NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed to confirm outside diagnosis.
  • Sufficient tumor tissue available from original diagnosis or subsequent biopsy for analysis of estrogen receptor and aromatase.
  • Tumor block or a minimum of 5 unstained slides.
  • Failed at least 1 prior FDA approved treatment for advanced NSCLC. 
  • Measureable disease by RECIST version 1.1.
  • Post-menopausal defined as:
    • Age ≥ 55 years and 1 year or more of amenorrhea;
    •  Age < 55 years and 1 year or more of amenorrhea with an estradiol assay < 20 pg/mL;
    • Surgical menopause with bilateral oophorectomy.
  • ECOG performance status 0, 1 or 2.
  • Life expectancy of 3 months or more in the opinion of the enrolling investigator and documented in the medical record. 
  • Adequate organ function within 14 days of study enrollment defined as: 
  • Hematology:
    • Absolute neutrophil count (ANC) ≥ 1500/mm³;
    • Platelets ≥ 100,000/mm³;
    • Hemoglobin ≥ 8 g/dL.
  • Biochemistry: 
    • Total Bilirubin within normal institutional limits.
    • AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN), except if there is known hepatic metastasis, wherein transaminases may be ≤ 5 x institutional ULN.
    • Serum creatinine ≤ 1.5 mg/dl or glomerular filtration rate > 50 ml/min.
  • Must have recovered to CTCAE v 4 Grade 1 or better from the acute effects of any prior surgery, chemotherapy or radiation therapy. Chronic residual toxicity (i.e., peripheral neuropathy) is permitted. 
  • A minimum time period must elapse between the end of a previous treatment and start of study therapy: 
    • 1 week from the completion of radiation therapy for brain metastases;
    • 4 weeks from the completion of chemotherapy or any experimental therapy;
    • 4 weeks from prior major surgery (such as open biopsy or significant traumatic injury).
  • Voluntary written consent before any research related procedures or therapy.


Exclusion Criteria:

  • Known active CNS disease.
  • If patient has history of brain metastases, the brain lesions must have been treated with radiation and/or surgery.
  • Patients should be neurologically stable and requiring ≤ 10mg oral prednisone equivalence of steroids per day.
  • Any toxicity from immune-related toxicity from prior immune therapy that would preclude further treatment with anti-PD-1/PDL-1 inhibitor or ongoing IR toxicity ≥ Grade 2.
  • Requiring > 10 mg prednisone equivalence of steroids per day for immune-related toxicity.
  • Inability or unwilling to swallow study drug.
  • Any gastrointestinal condition causing malabsorption or obstruction (e.g., celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome).
  • Currently using hormone replacement therapy (oral or patch) or/and phytoestrogen supplements (i.e., black cohosh).
  • Known hypersensitivity to exemestane or its excipients.
  • Any serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatment.
  • Prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free interval.
  • Concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort as these may significantly reduce the availability of exemestane.
Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic Health System — Mankato, MN

EA4181, A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients ≤ 70 Years Old With Untreated Mantle Cell Lymphoma

A Study to Compare Three Chemotherapy Regimens for the Treatment of Patients with Newly- diagnosed Mantle Cell Lymphoma

Jonas Paludo
All
18 years to 70 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-101203-P01-RST
19-011161
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

  • Baseline measurements and evaluations must be obtained within 6 weeks of randomization to the study. Abnormal PET or CT scans may constitute evaluable disease. Patient must have at least one objective measurable disease parameter. Measurable disease in the liver is required if the liver is the only site of lymphoma. 
  • MIPI score must be calculated and entered in Oncology Patient Enrollment Network (OPEN). 
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 
  • Patients must have untreated histologically confirmed mantle cell lymphoma, with cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescent in situ hybridization (FISH). The diagnosis must be confirmed by formal hematopathology review at the enrolling center.
  • Patients being treated with gastric reducing agents proton pump inhibitors must be switched to an alternative drug before starting acalabrutinib. 
    • Absolute neutrophil count (ANC) ≥ 1,000/mcL (obtained with 14 days of randomization). If disease includes marrow involvement or hypersplenism, please reference the below revised ANC requirement: 
      • ANC ≥ 500/mcL. 
    • Platelets ≥ 75,000 mcL (obtained with 14 days of randomization). If disease includes involvement or hypersplenism, please reference the below revised platelet requirement: 
      • Platelets ≥ 25,000/mcL.
    • Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) (obtained with 14 days of randomization). If disease includes hepatic infiltration or is causing biliary obstruction, or if elevated bilirubin is due to Gilbert's disease, please reference the below revised bilirubin requirements: 
      • Bilirubin ≤ 3 x institutional ULN.
    • Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 x institutional ULN (obtained with 14 days of randomization). If disease includes hepatic infiltration or is causing biliary obstruction, or if elevated bilirubin is due to Gilbert's disease, please reference the below revised AST/ALT requirements: 
      • AST/ALT ≤ 5 x institutional ULN.
  • Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (aPTT) in the absence of lupus anticoagulant) < 2 x institutional ULN (obtained with 14 days of randomization).
  • Patients receiving anticoagulant therapy (other than warfarin or equivalent vitamin K antagonists which are excluded), higher INR/aPTT may be permitted to enroll to this study after discussion with the primary investigator (PI). 
  • Creatinine ≤ institutional ULN, OR glomerular filtration rate (GFR) ≥ 40 mL/min/1.73 m^2 (obtained with 14 days of randomization). 
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. 
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. 
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional classification. To be eligible for this trial, patients should be class 2B or better. 
  • Patients must have a QT interval (QTc) ≤ 480 msec obtained within 14 days of randomization. 
  • Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until 12 months after the last dose of study treatment. All females of childbearing potential must have a blood test or urine study within 2 weeks 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: has achieved menarche at some point, has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). 
  • Women of childbearing potential and sexually active males must agree to use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 12 months after treatment ends. 


Exclusion Criteria:

  • Patients are not eligible if they require treatment with a strong cytochrome P450 (CYP) 3A inhibitor. 
  • Patients may not have received the following within 7 days prior to the first dose of study drug: 
    • Strong and moderate CYP3A inhibitors;
    • Strong and moderate CYP3A inducers.
  • Patients are ineligible if they have any of the following:
    • Malabsorption syndrome or disease significantly affecting gastrointestinal function;
    • Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease);
    • Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura).;
    • Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of first dose of study drug;
    • History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug;
    • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at study enrollment (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment);
    • History of severe allergic reaction attributed to compounds of similar chemical or biologic composition to rituximab, bendamustine, cytarabine, or acalabrutinib. 
  • Patients must be able to fulfill one of the following eligibility requirements pertaining to biospecimen availability for submission following randomization: 
    • Archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the original diagnostic biopsy is available for submission; or
    • If tumor tissue is not available, peripheral blood collected prior to initiation of protocol therapy will be submitted.
      • NOTE: Biospecimens must be submitted within 60 days following randomization to Adaptive Biotechnologies for ClonoSEQ ID molecular marker identification of unique clonal immunoglobulin deoxyribonucleic acid (DNA) sequence. If peripheral blood will be submitted, Adaptive Biotechnologies should be contacted prior to patient randomization for guidance pertaining to collection and submission requirements.
Biologic/Vaccine, Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

10183: A Pilot Study of Tazemetostat and MK-3475 (Pembrolizumab) in Advanced Urothelial Carcinoma

A Study to Evaluate Tazemetostat and Pembrolizumab to Treat Advanced Urothelial Carcinoma

Brian Costello
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-101223-P01-RST
19-011951
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Patients in Arm A may begin treatment after this registration.
  • Patients in Arm B will be required to undergo a second registration by meeting PD-L1  eligibility criteria. A tissue sample must be submitted for central analysis of PD-L1  after eligibility are confirmed.
  • Patients must have pathologically confirmed urothelial carcinoma.
    • Note: patients with mixed histology (with predominant urothelial carcinoma) are eligible.
  • Patients must have locally advanced or metastatic disease with either:
  • Arm A:  Disease progression during or following (within 12 months) platinum-based chemotherapy (cisplatin or carboplatin).
    • Note: no minimum number of cycles on platinum-based chemotherapy are required.
  • Patients who have had multiple rounds of platinum-based  chemotherapy with events of intermittent progressive disease (PD) are eligible as long as progression has been confirmed while on or within 12 months from platinum based therapy OR
  • Arm B:  Cisplatin ineligible as defined.
  • Patients in Arm B must also: 
    • Undergo central analysis of tissue for PD-L1 status; Be positive for PD-L1; 
    • If archival tissue is unavailable or insufficient for PD-L1 central analysis, a new biopsy must be performed;
    • Alternatively, patients who previously have had PD-L1 testing performed as standard of care via the Food and Drug Administration (FDA)-approved Dako PD-L1 immunohistochemistry (IHC) 22C3 PharmDx Assay companion diagnostic test and who have a combined positive score (CPS) of >= 10 may be eligible. In these cases, PD-L1 testing does not need to be repeated, and tissue does not need to be sent for central analysis.
  • All patients must have measurable disease in accordance with RECIST criteria version  (v) 1.1.
    • Note: radiological evaluation should occur within 28 days prior to study registration.
  • Patients must be naive to prior PD-L1 or EZH2 inhibitors.
    • Note: patients in Arm A should have received platinum-based chemotherapy only.  
  • Patients ≥ 18 years of age.
  • ECOG performance status ≤ 2.
  • Patients must have a blood smear or manual differential performed at screening showing  no significant morpholic abnormalities on complete blood count (CBC) testing.  
  • Leukocytes ≥ 3000/mcL (performed within 14 days prior to registration).  
  • Absolute neutrophil count (ANC) ≥ 1500/mcL (performed within 14 days prior to  registration).
  • Platelets ≥ 100 000/mcL (performed within 14 days prior to registration).
  • Hemoglobin ≥ 9 g/dL or ≥ 4.9 mmol/L (performed within 14 days prior to registration).
  • Creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine  clearance (CrCl) ≥ 30 mL/min for patient with creatinine levels > 1.5 x institutional  ULN (performed within 14 days prior to registration).
  • Creatinine clearance (CrCl) should be calculated per institutional standard.  
  • Glomerular filtration rate (GFR) can also be used in place of creatinine or CrCl. 
  • Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total  bilirubin levels > 1.5 x ULN (performed within 14 days prior to registration).
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and  alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x  ULN OR ≤ 5 x ULN for patients with liver metastases (performed within 14 days prior  to registration).
  • International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin  time (PTT) is within therapeutic range of intended use of anticoagulants (performed  within 14 days prior to registration)  
  • Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless patient is receiving  anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (performed within 14 days prior to registration).
  • The effects of MK-3475 and tazemetostat on the developing human fetus are unknown. For  this reason and because PD-1 inhibitors as well as EZH2 inhibitors are known to be  teratogenic, women of child-bearing potential and men must agree to use adequate  contraception (hormonal or barrier method of birth control; abstinence) prior to study  entry and for the duration of study participation. 
  • Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female patients of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication.
    • Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient. 
  • Male patients of childbearing potential 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 if this is the usual lifestyle and preferred contraception for the patient.
  • Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of MK-3475 or tazemetostat administration.
  • Participants who have the ability to understand and the willingness to sign an  Institutional Review Board (IRB) approved written informed consent document are  eligible OR Participants with impaired decision-making capacity (IDMC) who have a  legally authorized representative (LAR) or caregiver are eligible.  


Exclusion Criteria:
 

  • Patients with disease that is suitable for local therapy administered with curative intent are not eligible.
  • Patients who have had chemotherapy, targeted small molecule therapy, or radiotherapy  within 4 weeks prior to entering the study are not eligible.
  • Patients who have not recovered from adverse events due to prior anti-cancer therapy  (i.e., have residual toxicities > grade 1 per Common Terminology Criteria for Adverse Events [CTCAE] v.5 ) are not eligible.
    • Note: patients with ≤ grade 2 neuropathy or ≤ grade 2 alopecia or ≤ grade 3 audiometric hearing loss are an exception to this criterion and may qualify for the study.
    • Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Patients are not eligible who are currently participating and receiving study therapy  or have participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • Patients who have received transfusion of blood products (including platelets or red  blood cells) or administration of colony stimulating factors (including granulocyte  colony-stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor  [GM-CSF], or recombinant erythropoietin) within 4 weeks prior to the first dose of  treatment are not eligible.
  • Patients with a diagnosis of immunodeficiency or are receiving systemic steroid  therapy or any other form of immunosuppressive therapy within 7 days prior to the  first dose of trial treatment are not eligible.  
    • Note: the use of physiologic doses of corticosteroids may be approved after consultation with the study principal investigator (PI).
  • Patients with thrombocytopenia, neutropenia, or anemia of grade 3 (per CTCAE 5.0 criteria) or any prior history of myeloid malignancies, including myelodysplastic  syndrome (MDS) are not eligible. 
  • Patients with abnormalities known to be associated with MDS (e.g., del 5q, chr 7 abn)  and myeloproliferative neoplasms (MPN, e.g. JAK2 V617F) observed in cytogenetic  testing and deoxyribonucleic acid (DNA) sequencing are not eligible.
  • Patients with a prior history of T-cell lymphoblastic lymphoma (T-LBL) or T-cell acute  lymphoblastic leukemia (T-ALL) are not eligible.
  • Patients who have received prior PD-L1/PD-1/PD-L2 or EZH2 inhibitor therapy are not eligible.
  • Patients who have had a prior monoclonal antibody within 4 weeks prior to study day 1 are not eligible.
  • Patients with a known additional malignancy that is progressing or requires active  treatment are not eligible. Exceptions include basal cell carcinoma of the skin,  squamous cell carcinoma of the skin that has undergone potentially curative therapy,  or in situ cervical cancer.
  • Patients with known brain metastases or carcinomatous meningitis are 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.  
    • Note: patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging using the identical imaging modality for each assessment, either magnetic resonance imaging [MRI] or computed tomography [CT] scan, for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.
  • Patients with a history of allergic reactions attributed to compounds of similar  chemical or biologic composition to MK-3475 or tazemetostat are not eligible.
  • Patients with an active autoimmune disease that has required systemic treatment in the  past 2 years (i.e., with use of disease modifying agents, corticosteroids, or  immunosuppressive drugs) are not eligible.
    • Note: replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    • Patients with a history of (non-infectious) pneumonitis that required steroids or  current pneumonitis are not eligible.
  • Patients with a prolongation of corrected QT interval (Fridericia's correction formula  [QTcF]) of > 450 msec are not eligible.
  • Patients with major surgery within 3 weeks before the first dose of study drugs.  
    • Note: minor surgery (e.g., minor biopsy of an extracranial site, central venous catheter placement, shunt revision) has no restriction.
  • Patients must not have a history or current evidence of any condition, therapy, or  laboratory abnormality that might confound the results of the trial, interfere with  the patient's participation for the full duration of the trial, or is not in the best  interest of the patient to participate, in the opinion of the treating investigator.
  • Patients receiving any medications or substances that are strong inhibitors or  inducers of CYP3A =< 14 days prior to study treatment are not eligible .
    • Note: The study team should check a frequently-updated medical reference for a list of drugs to avoid or minimize use of. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
  • Patients who are unable to take oral medication OR have malabsorption syndrome or any  other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, vomiting) that  might impair the bioavailability of tazemetostat are not eligible.
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing  or active infection, interstitial lung disease or active, non-infectious pneumonitis,  symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,  uncontrolled arterial hypertension, stroke within 6 months prior to starting study  treatment, or psychiatric illness/social situations that would limit compliance with  study requirements are not eligible.
  • Pregnant women are excluded from this study because MK-3475 and tazemetostat are  agents with 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 MK-3475 and tazemetostat, breastfeeding should be  discontinued if the mother is treated with MK-3475 or tazemetostat.
  • MK-3475 may have adverse effects on a fetus in utero. Furthermore, it is not known if MK-3475 has transient adverse effects on the composition of sperm. Patients are excluded from this study if pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
  • Patients who are human immunodeficiency virus (HIV) positive may participate IF they  meet the following eligibility requirements:
    • They must be stable on their anti-retroviral regimen, and they must be healthy from an HIV perspective;
    • They must have a CD4 count of greater than 250 cells/mcL; 
    • They must not be receiving prophylactic therapy for an opportunistic infection.
  • Patients with a known history of hepatitis B (defined as hepatitis B surface antigen  [HBsAg] reactive) or known hepatitis C virus (defined as HCV ribonucleic acid [RNA]  [qualitative] is detected) infection are not eligible   -Note: no testing for hepatitis B and hepatitis C is required unless mandated by local health authority.
  • Patients who have received a live vaccine within 30 days of planned treatment start  are not eligible.
    • Note: seasonal flu vaccines that do not contain live virus are permitted.

PD-L1 ELIGIBILITY (ARM B ONLY):

  • Patients in Arm B must have positive PD-L1 status as confirmed by central analysis  prior to second step registration and treatment initiation.
    • Note: positive PD-L1 expression is defined as a combined positive score (CPS) ≥ 10 and will be confirmed in a report from HistoGeneX.  Alternatively, patients who previously have had PD-L1 testing performed as standard of care via the FDA-approved Dako PD-L1 IHC 22C3 PharmDx Assay companion diagnostic test and who have a combined positive score (CPS) of ≥ 10 may be eligible. In these cases, PD-L1 testing does not need to be repeated, and tissue does not need to be sent for central analysis.
Biologic/Vaccine, Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

ASTX727-06: An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)

A Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)

Aref Al-Kali
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101227-P01-RST
19-012633
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Adult patients, 18 years or older.
  • Previous participation in an Astex-sponsored ASTX727 clinical trial (including, but not limited to studies ASTX727-01, ASTX727-02, and ASTX727-04) in which the subject was treated with ASTX727 and was still on active treatment with ASTX727 at the time of study completion as determined by Astex. 
  • Subject is considered to be benefitting from ASTX727 treatment in the opinion of the treating investigator at the time of parent study completion (subjects must not be withdrawn from the parent study until eligibility for this study is confirmed). 
  • Subject is able to understand and comply with the study procedures and understands the risks involved in the study. 
  • Subject provides written informed consent before undergoing any study-specific procedure.
  • Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential must agree to practice 2 highly effective contraceptive methods of birth control and must agree not to become pregnant for 6 months after completing treatment; men with female partners of childbearing potential must agree to practice 2 highly effective contraceptive measures and must agree not to father a child while receiving ASTX727 and for at least 3 months after completing ASTX727 treatment.


Exclusion Criteria:

  • Any subject who, in the opinion of the investigator, may have other conditions, organ dysfunction, or for whom safety data from parent study participation suggests the risks of continuing treatment with ASTX727 may outweigh the benefits.
Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Accelerated Resolution Therapy for Cancer Related Trauma and Distress: A Pilot Study

A Study to Assess Accelerated Resolution Therapy for Cancer Related Trauma and Distress

Cindy Tofthagen
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-101254-P01-RST
19-006093
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • 18 years of age or older.
  • Able to read, write and understand English.
  • Undergoing chemotherapy, radiation therapy, CAR-T, or bone marrow transplant for a cancer diagnosis within the previous 3 years or have metastatic cancer.
  • A mean score of at least 1.1 on the Cancer and Treatment Distress (CTxD) or at least one item rated at a 3 (often true) or 4 (nearly all the time).
  • A minimum score of 3 on the PC-PTSD-5.
  • Denial of suicidal ideation or intent, with no evidence of psychotic behavior.
  • Participants must be willing and able to travel to Mayo Clinic outside of normally scheduled visits to participate in the study.


Exclusion Criteria:

  • Individuals under 18 years of age.
Other, Cancer emotional and psychosocial support and education, Chemotherapy, Immunotherapy for cancer, Mental health care, Radiation oncology AND/OR radiotherapy, Trauma therapy
Cancer
Anxiety about body function or health, Anxiety about treatment, Biological therapy for cancer, Bone marrow transplant, Bone marrow transplant present, Cancer treatment, Chemotherapy, Distress, Malignant neoplastic disease, Medical Oncology, Psychotherapy, Radiation therapy, Secondary malignant neoplastic disease, Victim of psychological trauma
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Feasibility of Transanal Robot-assisted Resection of Distal Colorectal Lesions Using the Medrobotics Flex® System: A Pilot Study

A Study to Determine the Feasibility of Transanal Robot-assisted Resection of Distal Colorectal Lesions Using the Medrobotics Flex? System

Louis Wong Kee Song
All
22 years to 99 years old
Feasibility
This study is NOT accepting healthy volunteers
0000-101255-P01-RST
19-009663
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Age > 22 years (minimum age approved for use).
  • Polypoid (0-Is) and non-polypoid (0-IIa, 0-IIb and 0-IIc) lateral spreading lesions according to Paris classification.
  • Colorectal lesions situated between 5 and 15 cm from the dentate line.
  • Colorectal mucosal lesions ranging from 1.5 to 7 cm in maximum diameter.
  • Colorectal subepithelial lesions < 2 cm in size.
  • Absence of uncorrectable bleeding disorder or coagulopathy (platelet count > 50,000 and INR < 1.5).
  • Ability to give informed consent.


Exclusion Criteria:

  • Inability to receive general anesthesia.
  • Presence of medical conditions for which a transanal approach is contraindicated (e.g., anal stricture, radiation proctopathy).
  • Excavated (0-III) colorectal lesions according to Paris classification.
  • Suboptimal colon preparation.
  • Clinical discretion of the provider.

 

Device
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment (ATACAR) Trial

A Study to Evaluate AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment

Joerg Herrmann
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101256-P01-RST
19-007547
Show full eligibility criteria
Hide eligibility criteria

Inclusion criteria:

- ≥ 18 years of age,

- New diagnosis of reduced cardiac function

- Prior anthracycline-based cancer therapy for lymphoma

Exclusion criteria:

- History of HF of any class and type, or diagnosis of cardiomyopathy prior to
anthracycline therapy

- On active therapy with a fibrate, niacin, or eplerenone

- History of myopathy/rhabdomyolysis

- History of statin intolerance

- Active hyperlipidemia

- History of gout

- Active liver disease

- Unexplained persistent elevations of serum transaminases

- Pregnancy

- Breast-feeding

- Hyperkalemia

- Addison disease

- eGFR <30 mL/minute/1.73 m^2

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/8/22. Questions regarding updates should be directed to the study team contact.

Drug, Drug therapy
Cancer, Cardiomyopathy, Lymphoma
Cancer treatment, Cardiac complication of procedure, Cardiomyopathy associated with another disorder, Cardiovascular system, Carvedilol, Chemotherapy, Hematopoietic system, Lisinopril, Malignant lymphoma, Malignant lymphoma (clinical), Medical Oncology, Pravastatin [INN:BAN], Spironolactone, carvedilol, lisinopril, pravastatin, spironolactone
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A Prospective Pilot Study Evaluating the Feasibility of Daily, Long-Term Intermittent Fasting for Men on PSA Surveillance Following Radical Prostatectomy for Localized, High-Risk Prostate Cancer

A Study to Evaluate the Feasibility of Daily, Long-Term, Intermittent Fasting for Men on PSA Surveillance Following Radical Prostatectomy

Robert Karnes
Male
18 years and over
Early Phase 1
This study is NOT accepting healthy volunteers
0000-101266-P01-RST
19-006675
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Biopsy-proven histological diagnosis of localized prostate cancer (pT2 or specimen confined pT3).
  • Having undergone radical prostatectomy (open or laparoscopic) with bilateral pelvic lymph node dissection.
  • Negative surgical margins on final specimen.
  • Men that decline adjuvant therapy.
  • Detectable serum PSA of 0.1 ng/mL or >.
  • 24 months or less since radical prostatectomy at time of study screening.


Exclusion Criteria:

  • Unable or unwilling to provide informed consent.
  • Treated prior to surgery with any form of hormone, antiandrogen, or androgen deprivation therapy.
  • Treated prior to surgery with any form of chemotherapy or radiotherapy.
  • Medical conditions/history that precludes subjects from following a fasting regimen including, but not limited to:
    • Diabetes Mellitus.
  • On hormone therapy (Casodex, GnRH agonist/antagonist).

 

 

Behavioral, Active surveillance of prostate cancer, Dietary regime, Modification of schedule of oral intake, Pelvic lymphadenectomy, Radical prostatectomy
Cancer, Prostate cancer
Active surveillance for prostate cancer, Cancer treatment, Local recurrence of malignant tumor of prostate, Lymphadenectomy, Malignant tumor of prostate, Medical Oncology, PSA test, Prostatectomy, Reproductive system
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

“Prescribing” Exercise to Cancer Patients at Risk for Falls

A Study to Evaluate Exercise for Cancer Patients at Risk of Falling

Aminah Jatoi
All
18 years to 99 years old
ERROR
This study is NOT accepting healthy volunteers
0000-101267-P01-RST
19-007775
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • 18 years of age or older at registration.
  • Any cancer type, as documented in the clinical record, other than non-melanoma skin cancer.
  • No issues (such as ongoing unstable angina or loss of a limb) that would preclude exercise.


Exclusion Criteria:

  • Younger than 18 years of age at registration.
Other, Exercise therapy, Fall prevention
Acute lymphocytic leukemia, Acute myelogenous leukemia, Aplastic anemia, Bladder cancer, Bone cancer, Brain tumor, Breast cancer, Cancer, Carcinoid tumor, Cervical cancer, Cholangiocarcinoma, Chronic lymphocytic leukemia, Chronic myelogenous leukemia, Chronic myelomonocytic leukemia, Colon cancer, Dysproteinemia, Endometrial cancer, Esophageal cancer, Essential thrombocythemia, Gallbladder cancer, Germ cell tumor, Hairy cell leukemia, Head and neck cancer, Hodgkin lymphoma, Hypereosinophilic syndrome, Immune thrombocytopenia, Kidney cancer, Large cell lung cancer, Large granular lymphocyte disorders, Leukemia, Liver cancer, Lung cancer, Lymphoma, Melanoma, Mesothelioma, Monoclonal gammopathy of undetermined significance, Multiple myeloma, Myelodysplastic syndromes, Myelofibrosis, Non-Hodgkin's lymphoma, Non-small cell lung cancer, Ovarian cancer, Pancreatic cancer, Pancreatic neuroendocrine tumor, Paroxysmal nocturnal hemoglobinuria, Polycythemia vera, Prostate cancer, Rectal cancer, Sarcoma, Skin cancer, Small bowel cancer, Small cell lung cancer, Soft tissue sarcoma, Squamous cell lung cancer, Stomach cancer, Systemic mastocytosis, Testicular cancer, Vaginal cancer, Vulvar cancer, Waldenstrom macroglobulinemia, Metastatic melanoma, Stage 4 melanoma
Nervous system, Acute lymphoid leukemia, Acute myeloid leukemia, disease, Aplastic anemia, At risk for falls, Cancer rehabilitation, Cancer treatment, Chronic myeloid leukemia, Chronic myelomonocytic leukemia, Digestive system, Essential thrombocythemia, Hairy cell leukemia (clinical), Hematopoietic system, Hemolytic anemia, Hodgkin's disease (clinical), Hypereosinophilic syndrome, Idiopathic thrombocytopenic purpura, Integumentary system, Large cell carcinoma of lung, Large granular lymphocytic leukemia, Malignant carcinoid tumor, Malignant melanoma, Malignant mesothelioma of pleura, Malignant neoplasm of brain, Malignant neoplasm of central nervous system, Malignant neoplasm of colon and/or rectum, Malignant neoplasm of endometrium of corpus uteri, Malignant neoplasm of liver, Malignant neoplasm of thorax, Malignant tumor of Islets of Langerhans, Malignant tumor of biliary tract, Malignant tumor of breast, Malignant tumor of cervix, Malignant tumor of esophagus, Malignant tumor of gallbladder, Malignant tumor of head and neck, Malignant tumor of kidney, Malignant tumor of lung, Malignant tumor of pancreas, Malignant tumor of prostate, Malignant tumor of rectum, Malignant tumor of small intestine, Malignant tumor of stomach, Malignant tumor of testis, Malignant tumor of urinary bladder, Malignant tumor of vagina, Malignant tumor of vulva, Medical Oncology, Monoclonal gammopathy of uncertain significance, Multiple myeloma, Musculoskeletal system, Myelodysplastic syndrome, Myelosclerosis with myeloid metaplasia, Non-Hodgkin's lymphoma (clinical), Non-small cell lung cancer, Paroxysmal nocturnal hemoglobinuria, Polycythemia vera (clinical), Primary malignant germ cell neoplasm, Pure red cell aplasia, Reproductive system, Respiratory system, Sarcoma of bone, Sarcoma of soft tissue, Secondary malignant neoplasm of female breast, Small cell carcinoma of lung, Squamous cell carcinoma of lung, Systemic mast cell disease, Urinary system, Waldenström macroglobulinemia, Exercise training
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Wound Infiltration with Liposomal Bupivacaine with or without Intrathecal Analgesia in Laparotomy for Gynecological Malignancy: A Randomized Controlled Trial

A Study to Evaluate Wound Infiltration with Liposomal Bupivacaine in Laparotomy for Gynecological Malignancy

Sean Dowdy
Female
18 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-101270-P01-RST
19-010500
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Age > 18 and ≤ 80 years old.
  • Elective surgery for suspected (based on consulting surgeon’s opinion
    •imaging, lab, path) gynecological malignancy, ERAS protocol.


Exclusion Criteria:

  • Inability to read or understand English.
  • Prehospitalization narcotic use if weekly average daily oral morphine equivalent of > 20 mg.
  • Chronic pain syndromes such as fibromyalgia.
  • Extensive surgery planned (surrogate for postop pain):
    • Planned ICU admission, abdominoperineal resection, exenteration, use of IORT, HIPEC.
  • Contraindication to neuraxial analgesia:
    • Coagulopathy:
      • INR >1.2 Current or predicted after surgery (e.g., planned right hepatic resection);
      • Thrombocytopenia (plts < 100);
      • Hemophiliac disease states (hemophilia, von Willebrand disease, etc.);
      • Patients receiving antithrombotic or thrombolytic therapy are excluded according to the ASRA guidelines (Reference: https://rapm.bmj.com/content/rapm/43/3/263.full.pdf).
    • Localized infection at the potential site of injection.
    • Significant developmental or structural spinal abnormalities that would preclude a safe spinal technique. These include spina bifida, tethered spinal cord, lumbar spinal fusion, and active lumbar radiculopathy.
  • Patients with stage 4 or 5 kidney disease (GFR less than 30 ml/min per 1.73 m^2).
  • Intolerance or allergy to opioids, acetaminophen, or amide-type local anesthetics.
  • Current pregnancy.
Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue

An Extension Study MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue

Lance Mynderse
Male
45 years and over
Feasibility
This study is NOT accepting healthy volunteers
0000-101275-P01-RST
19-011495
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
-Patients must have documented histological or cytological evidence of tumor(s) of the prostate. -Patients must be ≥ 45 years of age -Patients or their legal representative must be able to read, understand and sign an informed consent -Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging -Prostate cancer is diagnosed by MR image guided biopsies -Gleason Score ≤ 7; and 2 or less positive lesions on prior MR US fusion guided prostate biopsy. -A non MRI visible cancer detected via systematic standard biopsy will not be considered an exclusion condition provided the non-MRI visible cancer is singularly located in the contralateral hemisphere of the prostate; is Gleason 6 cancer; and comprises no more than 6mm linear extent of cancer in a single core on standard biopsy. -If any standard biopsy cores are positive on the same hemisphere of the prostate gland, they must be confirmed as likely to form a contiguous lesion with the target lesion detected on MRI and therefore be from the same location in the prostate as MR lesion was biopsied and proven to be cancerous. (e.g., Left/Right, Base, Mid Gland, Apex). -Prior mpMRI results dated within 120 days prior to ablation. -No metastatic disease as per NCCN guidelines (www.nccn.org)
•Bone scan indicated to r/o metastatic disease if clinical T1 and PSA > 20 or T2 and PSA > 10 -PSA < 15 ng/ml or PSA density < 0.15 ng/ml2 in patients with a PSA > 15 ng/ml -The patient has given written informed consent after the nature of the study and alternative treatment options have been explained.
Exclusion Criteria:
-Patients with known hypersensitivity to any of the components of the PEGylated AuroShell suspension (polyethylene glycol, gold). -Patients who are receiving concurrent investigational therapy or who have received investigational therapy within a period of 5 half-lives of the investigational therapy in questions prior to the day of dosing with PEGylated AuroShell particles (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication) -Patients with evidence of an active bacterial infection or with a fever ≥ 38.5 ºC (101.3 ºF) within 3 days of the first scheduled day of dosing -Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results. -The presence of 3 or more MR Visible lesions positive on biopsy. -The presence of extra capsular, seminal vesicle invasion or metastatic disease. -Patient is unable to tolerate MRI (foreign body; i.e. pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil, etc.…) -Patient with inability to follow up. -History of prior treatment for prostate cancer. -Acute urinary tract infection. -Lower urinary tract symptoms defined by International Prostate symptom score (IPSS) > 20 -Patients with renal insufficiency with an estimated glomerular filtration (EGF) <= 30 are excluded, as they will not be able to undergo gadolinium enhance MRI. -Patients with acute or chronic hepatic dysfunction as evidenced by clinically important (> grade 1) changes in AST, ALT, bilirubin, or albumin, or either ALP or GGT values. -Patients with uncontrolled coagulopathies who are at increased risk of bleeding, or with abnormal PT (INR) or PTT. -Altered mental status preventing consent or answering questions during conduct of the trial will be excluded for safety purposes. -Other medical or surgical conditions, especially involving the cardiac, respiratory, renal or hepatic organ systems that would either be unsafe for the patient, would limit study participation, or that would impede the determination of causality of any adverse events experienced during the conduct of this study.
Laser ablation of prostate, MRI guided high intensity focused ultrasound ablation of thalamus, Device
Cancer, Prostate cancer
Ablation, Cancer treatment, Malignant tumor of prostate, Medical Oncology, Prostate biopsy, Reproductive system
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

AALL1731, A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down Syndrome B Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy) (AALL1731)

A Study to Determine the Outcomes of Patients With Localized B Cell Lymphoblastic Lymphoma (B-LLy) When Treated With Standard Risk B-ALL Therapy

Asmaa Ferdjallah
All
365 days to 31 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-101280-P01-RST
19-009277
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- All B-ALL patients must be enrolled on APEC14B1 and consented to Eligibility Screening
(Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement
for B-LLy patients. B-LLy patients may directly enroll on AALL1731.

- Age at diagnosis:

- Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS).

- Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS).

- Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or
without DS).

- B-ALL patients without DS must have an initial white blood cell count < 50,000/uL
(performed within 7 days prior to enrollment).

- B-ALL patients with DS are eligible regardless of the presenting white blood cell
count (WBC) (performed within 7 days prior to enrollment).

- Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on
a bone marrow (BM) aspirate;

- OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis
can be established by a pathologic diagnosis of B-ALL on a BM biopsy;

- OR a complete blood count (CBC) documenting the presence of at least 1,000/uL
circulating leukemic cells;

- OR patient has newly diagnosed B-cell LLy Murphy stages I or II, with or without
Down syndrome.

- Note: For B-LLy patients with tissue available for flow cytometry, the criterion
for diagnosis should be analogous to B-ALL. For tissue processed by other means
(i.e., paraffin blocks), the methodology and criteria for immunophenotypic
analysis to establish the diagnosis of B-LLy defined by the submitting
institution will be accepted (diagnostic biopsy for B-LLy must be performed
within 14 days prior to enrollment).

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met.

- All patients and/or their parents or legal guardians must sign a written informed
consent.


Exclusion Criteria:


- Patient must not have secondary ALL that developed after treatment of a prior
malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior
history of transient myeloproliferative disease (TMD) are not considered to have had a
prior malignancy. They would therefore be eligible whether or not the TMD was treated
with cytarabine.

- With the exception of steroid pretreatment or the administration of intrathecal
cytarabine, patients must not have received any prior cytotoxic chemotherapy for
either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to
initiation of protocol therapy on AALL1731.

- For patients receiving steroid pretreatment, the following additional exclusion
criteria apply:

- Non-DS B-ALL patients must not have received steroids for more than 24 hours in
the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to
initiation of the steroids.

- DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV
steroids within 4 weeks of diagnosis.

- Patients who have received > 72 hours of hydroxyurea within 1 week (7 days) prior to
the start of systemic protocol therapy.

- B-ALL patients who do not have sufficient diagnostic bone marrow submitted for
APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted
containing > 1,000/uL circulating leukemia cells.

- Patient must not have acute undifferentiated leukemia (AUL).

- Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be
known prior to enrollment).

- Note: DS patients with CNS3 disease are eligible but will be assigned to the
DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior
to administration of any systemic or intrathecal chemotherapy, except for steroid
pretreatment.

- Non-DS B-ALL patients with testicular leukemia. (Note: DS patients with testicular
disease are eligible but will be assigned to the DS-High B-ALL arm).

- For LLy patients, the following additional exclusion criteria apply:

- T-Lymphoblastic Lymphoma.

- Morphologically unclassifiable lymphoma.

- Absence of both B-cell and T-cell phenotype markers in a case submitted as
lymphoblastic lymphoma.

- CNS positive disease or testicular involvement.

- M2 (5%
•25% blasts) or M3 (> 25% blasts) marrow.

- Patients with known Charcot-Marie-Tooth disease.

- Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL,
regardless of blast immunophenotype.

- Patients requiring radiation at diagnosis.

- Female patients who are pregnant since fetal toxicities and teratogenic effects have
been noted for several of the study drugs. A pregnancy test is required for female
patients of childbearing potential.

- Lactating females who plan to breastfeed their infants.

- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation.

Biologic/Vaccine, Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Acute lymphocytic leukemia, Cancer, Leukemia, Lymphoma, Non-Hodgkin's lymphoma
B-cell acute lymphoblastic leukemia, Biological therapy for cancer, Cancer treatment, Chemotherapy, Hematopoietic system, Medical Oncology
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

ACNS1723, A Phase 2 Study of Dabrafenib (NSC# 763760) with Trametinib (NSC# 763093) after Local Irradiation in Newly-Diagnosed BRAFV600-Mutant High-Grade Glioma (HGG) (IND# 145355) (ACNS1723)

Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

Jonathan Schwartz
All
3 years to 21 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-101282-P01-RST
19-010786
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • All clinical and laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated.
  • Laboratory values used to assess eligibility must be no older than 7 days at the start of therapy.
  • Laboratory tests need not be repeated if therapy starts within 7 days of obtaining labs to assess eligibility.
  • If a post-enrollment lab value is outside the limits of eligibility, or laboratory values are > 7 days old, then laboratory evaluations must be re-checked within 48 hours prior to initiating therapy. If the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.
  • A pre- and post-operative brain MRI with and without contrast, and a baseline spine MRI with contrast, must be obtained prior to enrollment. The requirement for post-operative MRI is waived for patients who undergo biopsy only.
  • Patients must be ≥ 3 years and ≤ 21 years of age at the time of enrollment.
  • Patients must have eligibility confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1:
    • Newly diagnosed high-grade glioma with BRAFV600-mutation;
    • Positive or negative results for H3 K27M by immunohistochemistry (IHC)
    • Histologically confirmed high-grade glioma (WHO Grade III or IV) including but not limited to: anaplastic astrocytoma (AA), anaplastic pleomorphic xanthoastrocytoma (aPXA), anaplastic gangliogliomas (aGG), glioblastoma (GB), and high-grade astrocytoma, NOS.
  • Patients must have had histologic verification of a high-grade glioma diagnosis. CSF cytology by lumbar puncture must be done if clinically indicated and determined to be safe prior to study enrollment. If cytology proves positive, the patient would be considered to have metastatic disease and would, therefore, be ineligible.
  • A pre- and post-operative brain MRI with and without contrast and a baseline spine MRI with contrast must be obtained prior to enrollment. The requirement for a post-operative MRI is waived for patients who undergo biopsy only. If the spine MRI is positive, the patient would be considered to have metastatic disease and would be ineligible.
  • Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age. See https://www.cogmembers.org/site/pages/default.aspx?page=Prot_reference_materials under Standard Sections for Protocols.
  • Adequate Bone Marrow Function defined as:
    • Peripheral absolute neutrophil count (ANC) ≥ 1000/µL;
    • Platelet count ≥ 100,000/µL (transfusion independent);
    • Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions).
  • Adequate Renal Function defined as:
    • Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m^2; or
    • A serum creatinine based on age/gender as follows:
    • 3 to < 6 years | Male 0.8 | Female 0.8;
    • 6 to < 10 years | Male 1.0 | Female 1.0;
    • 10 to < 13 years | Male 1.2 | Female 1.2;
    • 13 to < 16 years | Male 1.5 | Female 1.4;
    • ≥ 16 years | Male 1.7 | Female 1.4.
    • The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR32 utilizing child length and stature data published by the CDC.
    • Adequate Liver Function defined as:
      • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age; and
      • SGPT (ALT) ≤ 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
  • Central Nervous System Function defined as:
    • Patients with a seizure disorder may be enrolled if their seizures are well controlled while on non-enzyme inducing anticonvulsants permitted on this study.
  • Patients must be enrolled and protocol therapy must be projected to begin no later than 31 days after definitive surgery (Day 0). If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery.


Exclusion Criteria:

  • Patients with intrinsic brainstem or primary spinal cord tumors will be excluded.
  • Patients with metastatic disease (defined as neuraxis dissemination either by imaging or by cytology) will be excluded.
  • Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant for the treatment of HGG other than surgical intervention and/or corticosteroids.
  • Previous treatment with dabrafenib or another RAF inhibitor, trametinib or another MEK inhibitor, or an ERK inhibitor.
  • Patients with a history of a malignancy with confirmed activating RAS mutation.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib, trametinib, and their excipients.
  • Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, liver disease, or uncontrolled infection), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.
  • Presence of active gastrointestinal (GI) disease or other condition (e.g., small bowel or large bowel resection) that will interfere significantly with the absorption of drugs.
  • History of Hepatitis B Virus, or Hepatitis C Virus infection (patients with laboratory evidence of cleared Hepatitis B Virus and/or Hepatitis C Virus may be enrolled).
  • History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease, including any of the following:
    • Recent myocardial infarction (within the last 6 months);
    • Uncontrolled congestive heart failure;
    • Unstable angina (within last 6 months);
    • Clinically significant (symptomatic) or known, uncontrolled cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker) except sinus arrhythmia within the past 24 weeks prior to the first dose of study treatment;
    • Coronary angioplasty or stenting (within last 6 months);
    • Intra-cardiac defibrillators;
    • Abnormal cardiac valve morphology (≥ Grade 2) documented by echocardiogram.
  • Patients with a history or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR), or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension).
  • Patients with presence of interstitial lung disease or pneumonitis.
  • Female patients who are pregnant are ineligible since there is yet no available information regarding human fetal or teratogenic toxicities.
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of the study and for 4 months following discontinuation of study therapy.
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.
  • Sexually active patients of reproductive potential (male or female) are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 4 months following discontinuation of study therapy. Male patients (including those who have had a vasectomy) taking dabrafenib and trametinib combination therapy must use a condom during intercourse while on study and for 16 weeks after stopping treatment, and should not father a child during these periods. Women of childbearing potential should use. effective non-hormonal contraception during therapy and for 4 weeks following discontinuation of dabrafenib and at least 4 months following the last dose of trametinib in patients taking combination therapy.  Women should be advised that dabrafenib may decrease the efficacy of hormonal contraceptives and an alternate method of contraception, such as barrier methods, should be used.
  • All patients and/or their parents or legal guardians must sign a written informed consent.
  • All institutional, FDA, and NCI requirements for human studies must be met.

Eligibility last updated 9/28/21. Questions regarding updates should be directed to the study team contact.

Drug, Radiation
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

ACNS1831, A Phase 3 Randomized Study of Selumetinib Versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG) (ACNS1831)

A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma

Jonathan Schwartz
All
2 years to 21 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-101293-P01-RST
19-010788
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

  • Patients must have a body surface area (BSA) of ≥ 0.5 m^2 at enrollment.
  • Patients must have neurofibromatosis type 1 (NF1) based on clinical criteria and/or germline genetic testing.
  • Patients must be newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery.
  • For patients with optic pathway gliomas (OPGs): 
    • Newly-diagnosed patients with OPG are eligible if there are neurologic symptoms (including visual dysfunction, as defined below) or other exam findings associated with the tumor;
    • Previously-diagnosed patients with OPG are eligible if they have new or worsening neurologic symptoms (including visual dysfunction, as defined below) or have tumor growth;
    • For both newly-diagnosed and previously-diagnosed OPG, the patient may be eligible, irrespective of whether there has been tumor growth or other neurological symptoms or worsening, if they meet at least one of the following visual criteria: 
      • Visual worsening, defined as worsening of visual acuity (VA) or visual fields (VF) documented within the past year (by examination or history); OR
      • Significant visual dysfunction (defined as VA worse than normal for age by 0.6 logMAR [20/80, 6/24, or 2.5/10] or more in one or both eyes).
  • For patients with LGG in other locations (i.e., not OPGs): 
    • Newly-diagnosed patients with LGG are eligible if there are neurologic symptoms or other exam findings associated with the tumor;
      • NOTE: Newly-diagnosed patients with LGG without associated neurologic symptoms or exam findings are not eligible.
    • Previously-diagnosed patients with LGG are eligible if they have new or worsening neurologic symptoms or have tumor growth.
  • Although not required, if a biopsy/tumor resection is performed, eligible histologies will include all tumors considered LGG or low-grade astrocytoma (World Health Organization [WHO] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma.
  • Patients must have two-dimensional measurable tumor ≥ 1 cm^2.
  • Patients with metastatic disease or multiple independent primary LGGs are allowed on study.
  • Creatinine clearance or radioisotope glomerular filtration Rate (GFR) ≥ 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender within 7 days prior to enrollment as follows: 
    • Age; maximum serum creatinine (mg/dL)
    • 2 to < 6 years; 0.8 (male) and 0.8 (female)
    • 6 to < 10 years; 1 (male) and 1 (female)
    • 10 to < 13 years; 1.2 (male) and 1.2 (female)
    • 13 to < 16 years; 1.5 (male) and 1.4 (female) 
    • ≥ 16 years; 1.7 (male) and 1.4 (female).
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age within 7 days prior to enrollment (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect [unconjugated] bilirubin levels as long as their direct [conjugated] bilirubin is < 3.1 mg/dL).
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) ≤ 3 x upper limit of normal (ULN) = 135 U/L within 7 days prior to enrollment. For the purpose of this study, the ULN for SGPT is 45 U/L.
  • Albumin ≥ 2 g/dL within 7 days prior to enrollment.
  • Left ventricular ejection fraction (LVEF) ≥ 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram within 7 days prior to enrollment.
  • Corrected QT (QTc) interval ≤ 450 msec by electrocardiography (EKG) within 7 days prior to enrollment.
  • Absolute neutrophil count ≥ 1,000/uL (unsupported) within 7 days prior to enrollment.
  • Platelets ≥ 100,000/uL (unsupported) within 7 days prior to enrollment.
  • Hemoglobin ≥ 8 g/dL (may be supported) within 7 days prior to enrollment.
  • Patients with a known seizure disorder should be stable and should have not experienced a significant increase in seizure frequency within 2 weeks prior to enrollment.
  • Patients 2-17 years of age must have a blood pressure that is ≤ 95th percentile for age, height, and gender at the time of enrollment.
  • Patients ≥ 18 years of age must have a blood pressure ≤ 130/80 mmHg at the time of enrollment (with or without the use of antihypertensive medications). 
    • Note: Adequate blood pressure can be achieved using medication for the treatment of hypertension.
  • All patients must have ophthalmology toxicity assessments performed within 4 weeks prior to enrollment.
  • For all patients, an MRI of the brain (with orbital cuts for optic pathway tumors) and/or spine (depending on the site(s) of primary disease) with and without contrast must be performed within 4 weeks prior to enrollment.
  • For patients who undergo a surgery on the target tumor (not required), a pre- and post-operative* MRI of the brain (with orbital cuts for optic pathway tumors) or spine (depending on the site(s) of primary disease) with and without contrast must also be performed within 4 weeks prior to enrollment.
    • The post-operative MRIs should be performed ideally within 48 hours after surgery if possible.
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2.  Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
  • Patients must have the ability to swallow whole capsules. 
  • Patients must have receptive and expressive language skills in English or Spanish to complete the quality of life (QOL) and neurocognitive assessments.
  • 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 must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention is permitted.
  • Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible.
  • Patients may not be receiving any other investigational agents.
  • Patients with any serious medical or psychiatric illness/ condition, including substance use disorders likely in the judgement of the investigator to interfere or limit compliance with study requirements/treatment are not eligible.
  • Patients who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible.
  • Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
  • Lactating females who plan to breastfeed their infants are not eligible. 
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 12 weeks after stopping study therapy are not eligible.
    • Note: Women of child-bearing potential and males with sexual partners who are pregnant or who could become pregnant (i.e., women of child-bearing potential) should use effective methods of contraception for the duration of the study and for 12 weeks after stopping study therapy to avoid pregnancy and/or potential adverse effects on the developing embryo.
  • Cardiac conditions: 
    • Known genetic disorder that increases risk for coronary artery disease;
      • Note: The presence of dyslipidemia in a family with a history of myocardial infarction is not in itself an exclusion unless there is a known genetic disorder documented.
    • Symptomatic heart failure;
    • New York Heart Association (NYHA) class II-IV prior or current cardiomyopathy;
    • Severe valvular heart disease;
    • History of atrial fibrillation.
  • Ophthalmologic conditions: 
    • Current or past history of central serous retinopathy;
    • Current or past history of retinal vein occlusion or retinal detachment;
    • Patients with uncontrolled glaucoma;
    • If checking pressure is clinically indicated, patients with intraocular pressure (IOP) > 22 mmHg or ULN adjusted by age are not eligible;
    • Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor, or strabismus) or longstanding orbito-temporal plexiform neurofibroma (PN, such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study.
  • Treatments and/or medications patient is receiving that would make her/him ineligible, such as: 
    • Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E;
    • Recent surgery within a minimum of 2 weeks prior to starting study enrollment, with the exception of surgical placement for vascular access or cerebrospinal fluid (CSF) diverting procedures such as endoscopic third ventriculostomy (ETV) and ventriculo-peritoneal (VP) shunt.; 
      • Note: Patients must have healed from any prior surgery prior to enrollment.
    • Patients who have an uncontrolled infection are not eligible.
Drug, Other
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

ALTE03N1, Key Adverse Events After Childhood Cancer (ALTE03N1)

A Study to Identify Late-Occurring Complications in Childhood Cancer Survivors

Wendy Allen-Rhoades
All
Not specified
This study is NOT accepting healthy volunteers
0000-103584-P01-RST
19-002484
Show full eligibility criteria
Hide eligibility criteria

ELIGIBILITY CRITERIA
•CASES 

  • Diagnosis of primary cancer at age 21 or younger, irrespective of current age.
  • No prior history of allogeneic (non-autologous) hematopoietic cell transplant.
  • Development of one of the following key adverse events at any time following initiation of cancer therapy:
    • Cardiac dysfunction;
    • Ischemic stroke (IS);
    • Subsequent malignant neoplasm (SMN);
    • Avascular necrosis (AVN); please note: case enrollment has been closed due to achievement of target accrual. 
  • Submission of a blood specimen (or in certain cases a buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per the requirements.
    • Please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's white blood cell (WBC) is > 2,000.
  • Written informed consent from the patient and/or the patient?s legally authorized guardian. 
  • In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required. 

ELIGIBILITY CRITERIA
•CONTROLS:

  • CONTROL
    •Diagnosis of primary cancer at age 21 or younger, irrespective of current age.
  • CONTROL: No prior history of allogeneic (non-autologous) hematopoietic cell transplant. 
  • CONTROL: No clinical evidence of any of the following key adverse events:
    • Cardiac dysfunction (CD); please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's WBC is > 2,000;
    • Myocardial infarction (MI);
    • Ischemic stroke (IS);
    • Avascular necrosis (AVN);
    • Subsequent malignant neoplasm (SMN). 
  • CONTROL: Submission of a blood specimen (or in certain cases a buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per the requirements. 
  • CONTROL: Written informed consent from the patient and/or the patient?s legally authorized guardian. 
  • CONTROL: In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required.
Cancer, Heart attack, Heart failure, Stroke
Cancer treatment, Cancer treatment related morbidity, Cardiovascular system, Cardiovascular system complication of procedure, Cerebrovascular accident, Heart failure, Malignant neoplastic disease, Medical Oncology, Nervous system, Surviving free of recurrence of neoplastic disease, Cancer survivorship program
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

PULSE: A Randomized, Phase II Open Label Study of PanitUmumab RechaLlenge Versus Standard Therapy After Progression on Anti-EGFR Therapy in Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer (PULSE)

Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer

Zhaohui Jin
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-107380-P01-RST
19-010836
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Registered to Colorectal Cancer Liquid Biopsy Screening Protocol for Molecularly
Assigned Therapy (COLOMATE) ACCRU-GI-1611 and:

- COLOMATE Companion Trial Recommendation Form indicates patient qualifies to be
screened for a COLOMATE companion trial.

- COLOMATE Companion Trial Recommendation Form date of completion is =< 30 days
prior to randomization.

- Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum
that is metastatic and/ or unresectable.

- Documented wild-type in KRAS and NRAS (codons 12, 13, 59, 61, 117, and 146) and in
BRAF codon 600, based on tumor tissue taken from primary or metastatic site prior to
receipt of anti EGFR therapy.

- Progression, intolerance, or contraindication to a fluoropyrimidine (e.g.,
5-fluorouracil or capecitabine), oxaliplatin, irinotecan, and an anti-VEGF monoclonal
antibody (bevacizumab, ramucirumab, or aflibercept), and an anti-PD-1 monoclonal
antibody (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins
(dMMR) or is microsatellite instability-high (MSI-H)

- Disease progression after treatment with an anti-EGFR monoclonal antibody (cetuximab
and/or panitumumab) for at least 4 months (minimum of 8 biweekly treatments or 16
weekly treatments at full or partial dose).

- NOTE: Treatments do not need to be administered consecutively.

- NOTE: Dose reductions or delays are permitted.

- Greater than 90 days has elapsed between the most recent treatment with an anti-EGFR
therapy (cetuximab or panitumumab) and blood collection for COLOMATE ACCRU-GI-1611.

- At least one site of disease that is measurable by Response Evaluation Criteria in
Solid Tumors (RECIST) criteria that has not been previously irradiated; if the patient
has had previous radiation to the target lesion(s), there must be evidence of
progression since the radiation.

- Life expectancy >= 3 months per estimation of investigator.

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2.

- Absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support
(obtained =< 7 days prior to randomization).

- Platelet count >= 75,000 /mm^3 (obtained =< 7 days prior to randomization).

- Hemoglobin > 8.0 g/dL (obtained =< 7 days prior to randomization).

- Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 7 days prior to
randomization).

- Aspartate transaminase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver
involvement of their cancer) (obtained =< 7 days prior to randomization).

- Alanine aminotransferase (ALT) =< 2.5 x ULN (=< 5 x ULN for subjects with liver
involvement of their cancer) (obtained =< 7 days prior to randomization).

- Calculated creatinine clearance must be > 30 ml/min using the Cockcroft-Gault formula
(obtained =< 7 days prior to randomization).

- Women of child bearing potential and male partners of women of child bearing potential
must agree to use two medically accepted methods of contraception, one of them being a
barrier method during the study and for 2 months after the last dose of study drug(s).

- Negative serum pregnancy test done =< 7 days prior to randomization, for women of
childbearing potential only.

- NOTE: Women of childbearing potential include women who have experienced menarche
and who have not undergone successful surgical sterilization (hysterectomy,
bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal.
Postmenopause is defined as amenorrhea >= 12 consecutive months. NOTE: women who
have been amenorrheic for 12 or more months are still considered to be of
childbearing potential if the amenorrhea is possibly due to prior chemotherapy,
anti-estrogens, ovarian suppression or any other reversible treatment.

- Ability to complete questionnaire(s) by themselves or with assistance.

- Capable of understanding and complying with the protocol requirements and has signed
the informed consent document.

- Willing to return to enrolling institution for follow-up (during the active monitoring
phase of the study).

- Willing to provide tissue and blood samples for correlative research purposes.

- Willing to allow transfer of tissue and blood samples, clinical information, and
outcome data collected from this trial for future research.


Exclusion Criteria:


- Radiation therapy, hormonal therapy, biologic therapy, experimental therapy, or
chemotherapy for cancer < 21 days prior to randomization.

- Therapeutic anticoagulation with Vitamin-K antagonists (e.g., warfarin).

- Maximum mutant allele frequency (highest allele frequency reported for any gene
mutation) (MAF) less than 2% by Guardant360 assay.

- Detection of at least one of the following gene mutation(s) or amplification(s) by
Guardant360 assay.

- BRAF mutation mutant allele frequency (MAF) > 0.5%.

- EGFR mutation (MAF > 0.5%). Note: EGFR S492R, K467, and R451C mutations are not
an exclusion.

- ERBB2 (HER2) mutation (MAF > 0.5%) or amplification.

- KRAS mutation (MAF > 0.5%) or amplification.

- MET mutation (MAF > 0.5%) or amplification.

- NRAS mutation (MAF > 0.5%) or amplification

- Prior treatment with both TAS-102 and regorafenib (prior treatment with either TAS-102
or regorafenib is permitted).

- Unable to swallow oral tablets (crushing of study treatment tablets is not allowed).

- 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. Note: This includes impaired heart function or clinically
significant heart disease.

- Not recovered to baseline or Common Terminology for Adverse Events (CTCAE) version
(v)5.0 =< grade 1 from toxicity due to all prior therapies except alopecia,
oxaliplatin-related neuropathy, asymptomatic electrolyte abnormalities, and other
non-clinically significant adverse events.

- 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.

- Patients with known central nervous system (CNS) metastases. Note: Patients with
radiated or resected lesions are permitted, provided the lesions are fully treated and
inactive (based on repeat imaging >= 30 days after completion of definitive
treatment), patients are asymptomatic, and no steroids to control symptoms related to
CNS metastases have been administered for at least 30 days.

- Major surgical procedure, open biopsy, or significant traumatic injury =< 28 days
prior to randomization (=< 56 days for hepatectomy, open thoracotomy, major
neurosurgery) or anticipation of need for major surgical procedure during the course
of the study.

- Serious, non-healing wound, ulcer, or bone fracture.

- History of stroke (cerebrovascular accident), transient ischemic attack (TIA),
myocardial infarction (MI), unstable angina, cardiac or other vascular stenting,
angioplasty, or cardiac surgery =< 6 months prior to randomization.

- History of cardiac arrhythmias requiring anti-arrhythmic therapy other than beta
blockers, calcium channel blockers, or digoxin =< 6 months prior to randomization.

- Known history of congestive heart failure
•New York Heart Association (NYHA) >= class
II.

- Known history of human immunodeficiency virus (HIV) seropositivity, acute or chronic
active hepatitis B or C infection, or other serious chronic infection requiring
ongoing treatment.

- History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or
evidence of interstitial lung disease on baseline chest computed tomography (CT) scan.

- Subjects with any previously untreated or concurrent cancer that is distinct in
primary site or histology from colorectal cancer except cervical cancer in-situ,
treated basal cell carcinoma, or superficial bladder tumor. Note: Subjects surviving a
cancer that was curatively treated and without evidence of disease or biochemical
relapse (undetectable PSA for prostate cancer) for 3 or more years before
randomization are allowed. All cancer treatments must be completed at least 3 years
prior to randomization.

- Uncontrolled hypertension (systolic pressure > 150 mm HG or diastolic pressure > 90 mm
Hg [National Cancer Institute (NCI)-CTCAE v5.0]) on repeated measurement despite
optimal medical management.

- Evidence or history of bleeding diathesis or coagulopathy.

- Any hemorrhage or bleeding event >= NCI CTCAE v5.0 grade 3, =< 4 weeks prior to
randomization.

- Ongoing active infection > grade 2 NCI-CTCAE v5.0.

- Known or suspected allergy or hypersensitivity to any of the study drugs, study drug
classes, or excipients of the formulation given during the course of this trial.

- EXCEPTION: Cetuximab

- Any known history of malabsorption condition.

- Substance abuse, medical, psychological or social conditions that may interfere with
the subject's participation in the study or evaluation of the study results.

- Use of any herbal remedy (e.g. St. John's wort) =< 7 days prior to randomization.

- Use of strong CYP3A4 inducers or inhibitors =< 7 days prior to randomization.

Eligibility last updated 5/25/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Other, Behavioral
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Mayo Clinic Health TAPESTRY: Use of Genomic Sequencing in Clinical Practice (TAPESTRY)

Mayo Clinic Health TAPESTRY: Use of Genomic Sequencing in Clinical Practice

Konstantinos Lazaridis
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-121637-H01-RST
19-000001
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Registered Mayo Clinic patient.
  • Able to provide informed written consent.
  • E-mail and web access (for electronic consent, video education, registering with Helix and receiving results).
  • Ability to collect and ship saliva sample within the United States.


Exclusion Criteria:

  • Other co-morbidity which would in physician’s opinion interferes with patient’s ability to participate in the study (e.g., reduced ability to comprehend; e.g., dementia, intellectual disability, fluency in consent language).
  • Allogeneic Bone Marrow Transplant (e.g., samples from autologous bone marrow transplant recipients are acceptable if collected at least one month after transplant).
  • Active hematological cancer or history of a hematological cancer
  • Resident of the state of New York.
    • The Helix lab does not currently have New York state licensure.
  • Residents without a shipping address in the United States.
    • The Helix lab is unable to ship and receive samples internationally.
  • Of note: Women, who are pregnant, or planning to become pregnant, can take part in this study. However, this study does not replace prenatal genetic testing. If participants have these concerns, they will be encouraged to contact their obstetrics (OB) provider or a genetic counselor to discuss further.

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

Genetic
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Effect of Opioid Use and Fibromyalgia on Steroid Metabolome and Adrenal Function

Effect of Opioid Use and Fibromyalgia on Steroid Metabolome and Adrenal Function

Irina Bancos
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121638-H01-RST
19-000014
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Cross sectional study of prospectively enrolled 150 patients who will be enrolled from the pain clinic and endocrine clinic based on the following criteria:
    • Age 18 years and above;
    • Current opioid use of at least 20 MME per day, for at least 3 months;
    • Ability to provide informed consent;
    • Willingness to participate in study procedures;
    • Absence of known or suspected adrenal insufficiency of any other cause ( pituitary surgery, megace, etc.) or glucocorticoid exposure;
    • Pregnant women will be excluded on the basis that the steroid profile results could be skewed because of hormonal cause. Women of childbearing potential will be asked if they are pregnant and, if so, will then be excluded from participation.
  • Assessment – one-time assessment (cross-sectional study) to include the following:
    • Medical record review:
      • Type, dose and duration of opioid use, other medication use and steroid use;
      • Demographic information;
      • Comorbidities;
      • Type of pain/indications for opioid therapy.
    • Health interview:
      • Confirmation of duration and dose of opioids;
      • Review of medications and comorbidities;
      • Review of exogenous steroid use;
      • Smoking history;
      • AddiQOL survey;
      • SF36 survey.
  • Physical assessment:
    • 6 minute walk test.
  • Biomaterial collection and measurements:
    • Morning ACTH, cortisol and DHEAS measurements (clinical measurement);
    • 24 h urine collection for cortisol (clinical measurement) and steroid profiling assessment (research test).
Narcotic drug user
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN