Valproic Acid With Temozolomide and Radiation Therapy to Treat Brain Tumors
Completed · Phase 2
Conditions studied: High Grade Gliomas, Brain Tumors
In brief
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.
Key facts
- Study ID
- NCT00302159
- Run by
- National Cancer Institute (NCI)
- People needed
- 43
- Starts
- 2006-03-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2016-08-18
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Prior therapy:
- Patients who have previously received valproic acid.
- Patients who have previously received radiation therapy to the brain.
- Patients who have received chemotherapy for the treatment of their high grade glioma or who are currently receiving other investigational chemotherapeutic agents.
- Patients with a known history of disorders of urea metabolism.
- Concurrent therapy:
- The concurrent use of sulfamethoxazole, salicylates or naproxen is not allowed.
- Patients with a history of or concurrent second malignancy other than non-melanoma skin cancer or cervical cancer less than 3 years since GBM diagnosis.
- Pregnant or breast-feeding females are excluded because of the potential mutagenic effects on a developing fetus or newborn.
- Clinically significant unrelated systemic illness which in the judgement of the Principal or Associate Investigator would compromise the patient's ability to tolerate this therapy or are likely to interfere with the study procedures or results, including but not limited to Insulin dependent diabetes.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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