UVA Health System seeks men and women 18 years and older, who have been diagnosed with a meningioma or brain tumor which has gotten bigger or grew back or progressed to participate in a clinical research study. The purpose of this study is to test good and bad effects of two different drugs against meningioma tumors with altered genes or mutations. Today, therapy for meningioma is the same for all patients and is not based on tumor genetic testing. This trial is trying to see if tumor mutational testing would be helpful at guiding treatment in patients such as you.
Vismodegib, one of the drugs used in this study, has already been FDA-approved to treat basal cell cancer, which is a type of skin cancer. The second medication, GSK2256098, has been tested in other cancers, and researchers hope to learn if either of the study drugs will shrink the meningioma by at least one-half compared to its present size.
Adults with progressive meningioma are eligible to undergo additional screening procedures to see if they are eligible to participate. Patients who meet eligibility criteria, complete the screening process, and are enrolled into the study will be assigned to receive either Vismodegib or GSK2256098 depending on the results of the tumor mutational testing.
Both Vismodegib and GSK2256098 are taken orally or by mouth and you would receive them until your tumor grows or you experience unacceptable drug effects. Participants in this study will have routine neurological and physical exams performed as well as tumor evaluations done by MRI. Blood and urine samples will be collected for routine, or standard of care, testing.
Additional blood will be collected during the study for specific research tests required by the study and questionnaires related to fatigue are included. Routine care expenses will be billed to the patient and or their insurance provider. The study drug will be provided free of charge. Study participants will not receive any payment for participating in this study.
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