January 18, 2022 Brain

Protocol – Alliance A071401

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

SCHEMA Alliance A071401

Eligibility:

Pre-Registration:

  1. Local diagnosis of meningioma and have tissue available for central path review and integral biomarker testing.

Registration Eligibility:

  1. Presence of specific SMO/PTCH1, NF2 or AKT1/PIK3CA./CDK pathway mutations.
  2. Progressive or residual disease.
  3. Measurable disease as defined by a bi-dimensionally measurable.
  4. Target lesion on MRI brain or CT head images (MRI preferred).
  5. No chemotherapy, other investigational agents within 28 days of study treatment.
  6. No other concurrent investigational agents or other meningioma directed therapy (chemotherapy, radiation)
  7. Greater than 24 weeks must have elapsed from completion of radiation treatment (XRT, brachytherapy, radiosurgery) to registration.
  8. Steroid dosing stable for at least 4 days prior to registration.
  9. ECOG Performance Status 0-2.
  10. Stable for lesions for 6 months for patients with history of NF.
  11. No metastatic meningiomas.
  12. No history of allergic reactions attributed to compounds of similar biologic composition to assigned study drug.


February 23, 2021 Brain

ProtocolAlliance A071702

SCHEMA Alliance A071702

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!

Eligibility:

Pre-Registration:

  1. Histologically-confirmed glioblastoma presenting at first or second recurrence including secondary glioblastoma.
  2. Presence of measurable, as defined by a bidimensionally measurable lesion on MRI with a minimum diameter of 10mm in both dimensions, prior to resection or biopsy of recurrent tumor.
  3. Tissue available from surgical resection or biopsy of recurrent tumor less than or equal to 28 days prior to pre-registration or planned surgery or biopsy of recurrent tumor less than or equal to 28 days after pre-registration.
  4. Does not require greater than 4 mg dexamethasone daily beyond the perioperative period defined as the less than or equal to 2 weeks after surgical procedure.
  5. No active autoimmune disease or history of autoimmune disease.
  6. No prior treatment with checkpoint blockage therapies or bevacizumab.
  7. No prior treatment with laser ablation at the time of recurrent tumor tissue sampling. Patients who have previously undergone laser ablation greater than or equal to 4 months prior to recurrent tumor tissue sampling can be included.
  8. Must be at least 18 years of age.
  9. ECOG performance status 0-2.
  10. Adequate marrow and organ function.
  11. Able to undergo brain MRI with contrast


February 22, 2021 Brain

 ProtocolAlliance – A071701

SCHEMA Alliance 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.

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