At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed glioblastoma multiforme (GBM) diagnosed within 6 weeks prior to enrollment
- ✓Age >18 years with life expectancy >8 weeks
- ✓Candidate for definitive external beam radiotherapy
- ✓ECOG performance status 0, 1, or 2
- ✕Prior valproic acid therapy
- ✕Prior radiation therapy to the brain
- ✕Prior chemotherapy for high grade glioma or concurrent investigational chemotherapy
- ✕History of disorders of urea metabolism
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Clinical Trial of the Histone Deacetylase Inhibitor Valproic Acid in Combination With Temodar and Radiation Therapy in Patients With High Grade Gliomas: Multi-Institutional Trial
In Brief
A Phase 2 clinical trial evaluating adjuvant therapy, Temozolomide, and 2 other interventions for High Grade Gliomas and Brain Tumors. Completed, enrolled 43 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
Orally 75mg/m\^2 first day of radiation until completion. Restart 4 weeks post radiation.
Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.