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October 15, 2019 Genomic Based Trial

Research & Trial Information

SCHEMA

Protocol#: TAPUR

Cancer Type: Genomic Based Trial

Patient Eligibility:

  1. Patient (age 12 years*) with a histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the treating physician, no such treatment is available or indicated.

  2. ECOG performance status 0-2.
  3. Patients must have measurable or evaluable disease. Patient’s whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumor marker only) are NOT eligible.
  4. Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression. The genomic or IHC test used to qualify a patient for participation in TAPUR may have been performed on any specimen of the patient’s tumor obtained at any point during the patient’s care at the discretion of the patient’s treating physician. Genomic assays performed on cell-free DNA in plasma (“liquid biopsies”) will also be acceptable if the genomic analysis is performed in a laboratory that meets the criteria described above. Note: Eligible genomic tests may include any of the following technologies: fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), comparative genomic hybridization (CGH), next generation sequencing (NGS), whole exome sequencing (WES). The test may have been performed on a fresh or paraffin-embedded specimen of the primary tumor or a metastatic deposit or on cell free DNA derived from plasma, as determined by the treating physician, and must reveal a potentially actionable genomic variant.

  5. Have a tumor genomic profile for which treatment with one of the FDA approved targeted anti-cancer therapies included in this study has potential clinical benefit based on the criteria.

  6.  For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.

  7.  No ongoing toxicity > CTCAE grade 2, other than peripheral neuropathy, related to antitumor treatment that was completed within 4 weeks prior to registration. Patients with ongoing peripheral neuropathy of CTCAE grade 3 will be excluded.

  8. No previous treatment with the selected study drug for the same malignancy.
  9. If the patient’s tumor has a genomic variant known to confer resistance to an anticancer agent available in this study, the patient will not be eligible to receive that agent but will be eligible to receive other drugs available in this study if all inclusion and exclusion criteria are met for that drug.

  10.  If the patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates) or ongoing castration-intent therapy for prostate cancer. These medications must have been started ≥ 1 month prior to enrollment on this study. Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific exclusion criteria.
  11. Patients with primary brain tumors are excluded. Patients with known progressive brain metastases determined by serial imaging or declining neurologic function in the opinion of the treating physician are not eligible. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month prior to study enrollment.

  12. Patients with preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.

  13. Patients with left ventricular ejection fraction (LVEF) known to be < 40% are not eligible.

  14.  Patients with stroke (including TIA) or acute myocardial infarction within 4 months before the first dose of study treatment are not eligible.

  15. Patients with acute gastrointestinal bleeding within 1 month of start of treatment are not eligible.

  16.  Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, severe psychiatric illness situations, or anticipated or planned anti-cancer treatment or surgery.

  17. Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician, are not eligible to receive that drug.

  18.  Patients whose disease is not measurable or assessable by radiographic imaging or physical examination (e.g., elevated serum tumor marker only) are not eligible.



October 15, 2019 Genomic Based Trial

Research & Trial Information

SCHEMA EAY131

Protocol#: ECOG – EAY131 (MATCH)

Cancer Type: Genomic Based Trial

Patient Eligibility:

  1. Patients must be 18 years of age. Because no dosing or adverse event data are currently available on the use of study investigational agents in patients < 18 years of age, children are excluded from this study.
  2. Patients must have histologically documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma requiring therapy. Patients must have progressed following at least one line of standard systemic therapy and there must not be other approved/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls). Patients who cannot receive other standard therapy that has been shown to prolong overall survival due to medical issues will be eligible, if other eligibility criteria are met. If the patient is currently receiving therapy, the clinician must have assessed that the current therapy is no longer benefitting the patient prior to enrolling on MATCH, regardless of whether it is considered standard. OR Patients for whose disease no standard treatment exists that has been shown to prolong overall survival.
  3. No other prior malignancy is allowed except for the following:a) adequately treated basal cell or squamous cell skin cancerb) in situ cervical cancer

    c) adequately treated Stage I or II cancer from which the patient is currently in complete remission

    d) any other cancer from which the patient has been disease-free for 5 years.

  4. Patients must have measurable disease.
  5. Patients must meet the criteria below and have received results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific select subprotocols. The following requirements apply:The outside laboratory specifically notified the site that patient may be a potential candidate for MATCH due to a detected “rare variant. The outside lab reports are NOT sufficient for this purpose. Patents with an applicable “rare variant” must be able to meet the eligibility criteria for the appropriate subprotocols within 4 weeks following notification of treatment assignment. Registration to Step 0 occurs after stopping prior systemic anti-cancer therapy. There is no specific duration for which patients must be off treatment prior to registration to Step 0, as long as the eligibility criteria has been met. Patients may have received other non-targeted, immunotherapy or targeted treatment between the prior genetic testing at the outside lab and registration to Step 0. The decision to stop such treatment in favor of participation in MATCH, if no further clinical benefit is expected, is per the treating physician’s discretion.
  6. Patient must not require the use of full dose coumarin-derivative anticoagulants such as warfarin. Low molecular weight heparin is permitted for prophylactic or therapeutic use. Factor X inhibitors are permitted.
  7. Patients must have ECOG performance status ≤ 1 and a life expectancy of at least 3 months.
  8. Patients must not currently be receiving any other investigational agents.
  9. Any prior therapy, radiotherapy (except palliative radiation therapy of 30 Gy or less), or major surgery must have been completed ≥ 4 weeks prior to start of treatment. All adverse events due to prior therapy have resolved to a grade 1 or better (except alopecia and lymphopenia) by start of treatment. Palliative radiation therapy must have been completed at least 2 weeks prior to start of treatment. The radiotherapy must not be to a lesion that is included as measurable disease.
  10. Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy 4 weeks prior to start of treatment.
  11. Patients must have discontinued steroids 1 week prior to registration to Step 0 and remain off steroids thereafter, except as permitted (see below). Patients with glioblastoma (GBM) must have been on stable dose of steroids, or be off steroids, for one week prior to registration to treatment step (Step 1, 3, 5, 7).

Genesys Hurley Cancer Institute

302 Kensington Avenue
Flint, MI 48503

810-762-8226 | 888-762-8675

Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium

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