April 7, 2020 Brain

Clinical Trial Information

Schema A071701

PROTOCOL: Alliance-A071701

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

Pre-Registration Eligibility:

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

Registration Eligibility:

  1. Histologically confirmed metastatic disease to the brain from any solid tumor defined by one of the following:
  2. Untreated measurable lesions in patients who have received surgery and/or SRS to one or more other lesions.
  3. Residual or progressive lesions after surgery if asymptomatic.
  4. Prior WBRT and/or SRS and then lesions progressed or new lesions.
  5.   Not previously been treated with cranial radiation
    (e.g. WBRT or SRS) are eligible, but such patients
    must be asymptomatic or neurologically stable from their CNS metastases. Measurable CNS disease (>10 mm) .
  6. Ability to obtain MRIs.
  7. New or progressive CNS lesions after systemic therapy or prior radiotherapy.
  8. No surgery within 2 weeks prior to or after registration.
  9. No chemotherapy within 14 days prior to registration.
  10. For melanoma, progression after immunotherapy or for BRAF positive melanoma, BRAF/MEK inhibitors .
  11. For lung cancer, failed EGFR therapies.
  12. For HER2-positive breast cancer received prior HER-2 directed therapy in the metastatic setting.
  13. For triple negative breast cancer (TNBC), at least one chemotherapy in the metastatic setting.
  14. For ER/PR+ breast cancer, at least one endocrine therapy in the metastatic setting.
  15. Breast cancer patients who have received ribociclib or palbociclib are eligible as long as there is documentation of CDK4 pathway alteration on a biopsy at the point of progression post-ribociclib or palbociclib.
  16. Tissue available for sequencing (any brain metastasis tissue and extracranial site from any prior resection or biopsy) Presence of clinically actionable alteration in NTRK, ROS1, CDK pathway or PI3K pathway in both a brain metastasis and extracranial site.
  17. ECOG Performance Status 0-2.

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

Newsletter

Ⓒ 2020 Genesys Hurley Cancer Institute | All Rights Reserved.