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Genomically Guided Treatment Trial in Brain Metastases

 ProtocolAlliance – A071701

SCHEMA A071701

Please Note: Below is partial eligibility, please contact GHCI Research Department for full eligibility requirements at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Pre-Eligibility:

  1. Tissue available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy). If the patient does not have any evidence of extracranial disease, or if there is insufficient extracranial tissue for profiling, brain metastasis tissue is sufficient for eligibility.

Registration:

  1. Histologically confirmed parenchymal metastatic disease to the brain from any solid tumor. Note: this includes patients that have controlled extracranial disease with progressive intracranial metastasis, as well as patients that have progressive intracranial and extracranial disease.
  2. New or progressive brain metastases.
  3. Measurable CNS disease.
  4. Ability to obtain MRIs with contrast.
  5. No surgery within 2 weeks prior to or after registration.
  6. No chemotherapy within 14 days prior to registration.
  7. Presence of clinically actionable alteration in NTRK, ROSI, or CDK pathway or P13K in both a brain metastasis and extracranial site per central review.
  8. Must be at least 18 years of age.
  9. No uncontrolled medical comorbidities per investigator discretion.
  10. Radiation to symptomatic non-target sites within neural axis is allowed prior to registration without washout.