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Clinical Trial 18660
Cancer Type: Neurologic Oncology
Interventions:GSK2256098; Vismodegib (Erivedge)
Study Type: Treatment
Phase of Study: Phase II
- Peter Forsyth
Phase II Trial of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas With SMO/AKT/NF2 Mutations
The purpose of this study is to test good and bad effects of these two different study drugs against meningioma tumors with altered genes. 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.
2.0 OBJECTIVES 2.1 Primary objectives: 2.1.1 To determine the activity of a SMO inhibitor in patients with meningiomas harboring SMO mutations as measured by 6-month PFS and response rate. 2.1.2 To determine the activity of a FAK inhibitor in patients with meningiomas harboring NF2 mutations as measured by 6-month PFS and response rate. 2.2 Secondary objectives: 2.2.1 To determine overall survival and progression-free survival of SMO and FAK inhibitors in patients with meningioma. 2.2.2 To determine adverse event rates of SMO and FAK inhibitors in patients with meningioma. 2.3 Correlative science objectives: 2.3.1 To evaluate genetic biomarkers in meningioma. 2.3.2 To evaluate dynamic contrast enhanced MRI during treatment with SMO and FAK inhibitors for meningioma.