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!
Eligibility:
Pre-Registration:
- Local diagnosis of meningioma and have tissue available for central path review and integral biomarker testing.
Registration Eligibility:
- Presence of specific SMO/PTCH1, NF2 or AKT1/PIK3CA./CDK pathway mutations.
- Progressive or residual disease.
- Measurable disease as defined by a bi-dimensionally measurable.
- Target lesion on MRI brain or CT head images (MRI preferred).
- No chemotherapy, other investigational agents within 28 days of study treatment.
- No other concurrent investigational agents or other meningioma directed therapy (chemotherapy, radiation)
- Greater than 24 weeks must have elapsed from completion of radiation treatment (XRT, brachytherapy, radiosurgery) to registration.
- Steroid dosing stable for at least 4 days prior to registration.
- ECOG Performance Status 0-2.
- Stable for lesions for 6 months for patients with history of NF.
- No metastatic meningiomas.
- No history of allergic reactions attributed to compounds of similar biologic composition to assigned study drug.