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
- Histone deacetylase inhibitors (HDACi) have recently been shown to enhance the
radiosensitivity of glioma cells both in vitro and in vivo.
- Valproic acid has also recently been demonstrated to be a potent HDAC.
- Valproic acid has a long clinical history in patients with and without brain tumors and
is known to cross the blood-brain barrier. However, the use of valproic acid in
combination with temozolomide and radiotherapy for patients with high-grade gliomas has
never been tested.
-The primary measure of efficacy will be progression free survival and overall survival.
- Patients greater than 18 years old
- Diagnosis glioblastoma multiforme
- ECOG performance status of 0, 1, or 2.
- Patients who have not been previously treated with chemotherapy or radiation
- This is a Phase II trial to determine the efficacy of valproic acid in combination with
external beam radiation therapy and temozolomide in patients with high-grade gliomas.
- Patients will be treated with external beam radiation therapy in a standard manner with
temozolomide given daily during the radiation. The valproic acid will be administered
daily beginning one week prior to the first day of irradiation and continuing until the
completion of chemoradiation.
- We anticipate that accrual to this trial of 41 patients will take approximately 1 year.
Masking: Open Label, Primary Purpose: Treatment
Kevin A Camphausen, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|
|University of Pennsylvania||Philadelphia, Pennsylvania 19104|
|Virginia Commonwealth University||Richmond, Virginia|