a study on Meningioma
This phase II trial studies how well vismodegib and focal adhesion kinase (FAK) inhibitor GSK2256098 work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegib and FAK inhibitor GSK2256098 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Phase II Trial of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas With SMO/AKT/NF2 Mutations
Each arm is a prospective, one-stage phase 2 study evaluating the efficacy of smoothened receptor SMO or FAK inhibitors in patients with SMO-mutated or neurofibromin 2 (NF2)-mutated meningiomas, respectively. There will be a separate phase 2 arm for each of the two tumor mutation groups and each tumor grade cohort. Patients with recurrent or progressive Grade I-III meningiomas will be eligible for this trial. Samples will undergo central pathology review. Patient's tumor samples will be tested for the presence of SMO or NF2 mutations. Patients harboring SMO or NF2 mutations and who meet eligibility criteria will be enrolled. Within each arm, there will be two different patient cohorts based on histology: grade I versus II/III meningiomas.
The primary and secondary objectives are described below.
NOTE: Afuresertib, the agent identified for patients with AKT1 mutation is not currently available. Testing for the AKT1 mutation will commence once afuresertib becomes available and sites are notified via a protocol amendment. Tumor samples will only be tested for SMO and NF2 mutations until further notice.
Patients will be followed for 2 years after completion of treatment.
Intracranial Meningioma Recurrent Meningioma
For people ages 18 years and up
Pre-Registration Eligibility Criteria
Central Pathology Review Submission: This review is mandatory prior to registration to confirm eligibility.
Registration Eligibility Criteria
Documentation of Disease:
Not pregnant and not nursing:
Required Initial Laboratory Values:
ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)*
Except in case of Gilbert's disease**
Aspartate aminotransferase/alanine aminotransferase***
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