Valproic Acid With Temozolomide and Radiation Therapy to Treat Brain Tumors

Study Summary

Background: * Radiation therapy with temozolomide (an anti-cancer drug) is standard therapy for treating brain tumors called glioblastomas. * The drug valproic acid, currently approved for treating seizures, has been shown in laboratory tests to increase the radiosensitivity of glioma cells. Objectives: -To determine the effectiveness of adding valproic acid to standard treatment with radiation therapy and temozolomide for treating glioblastoma. Eligibility: -Patients 18 years of age and older with glioblastoma multiforme who have not been previously treated with chemotherapy of radiation. Design: * This Phase II trial will enroll 41 patients. * Patients will receive radiation therapy to the brain once a day, Monday through Friday, for 6 1/2 weeks. * Patients will take temozolomide once a day by mouth, Monday through Friday, during the period of radiation treatment. Starting 4 weeks after radiation therapy, patients will take temozolomide once a day for 5 days every 28 days for a total of six cycles. * Patients will receive valproic acid by mouth twice a day beginning 1 week prior to the first day of radiation therapy and continuing until the completion of chemotherapy and radiation therapy. * Patients will have follow-up visits 1 month after completing therapy, then every 3 months for 2 years, and then every 6 months for 3 years. Follow-up includes a physical examination, blood tests and magnetic resonance imaging of the brain.

Primary Outcome

Progression free survival is the interval from initiation of treatment on protocol to symptomatic or radiographic progression. Progressive disease is a \>25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol.

Interventions

• DRUG Temozolomide
• RADIATION Radiation therapy
• DRUG Valproic Acid
• PROCEDURE adjuvant therapy