Valproic Acid With Temozolomide and Radiation Therapy to Treat Brain Tumors
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
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.