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Investigator(s):
Kevin A. Camphausen, M.D. Principal Investigator Phone: 301-496-5457 camphauk@mail.nih.gov
Referral Contact(s):
Sharon L. Smith, R.N., M.S., O.C.N., C.C.R.P. Research Nurse Phone: 301-496-5457 Fax: 301-480-2347 smiths@mail.nih.gov

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Key Eligibility Criteria:

• Histologically confirmed diagnosis of glioblastoma multiforme (GBM) established by biopsy or resection no more than 6 weeks prior to enrollment
• Patients with resectable disease must have undergone subtotal or total resection prior to beginning study therapy
• Candidate for definitive external beam radiotherapy
• Patients must have a primary medical oncologist in the community who is wiling to collaborate with the ROB staff in the clinical management of the patient, specifically in the prescription of Temozolomide and toxicity monitoring in the adjuvant phase
• ≥ 18yrs years of age
• No prior valproic acid
• No prior radiotherapy to the brain
• No prior chemotherapy for GBM
• No concurrent sulfamethoxazole, salicylates, or naproxen
• No other concurrent anticancer chemotherapy, immunotherapy, or investigational agents
• Concurrent non-investigational steroids or anticonvulsants allowed
• Absolute granulocyte count > 1,500/mm³ , Hemoglobin > 10 g/dL, Platelet count > 100,000/mm³ , Bilirubin < 2 times upper limit of normal (ULN), SGOT/SGPT < 2 times ULN, Creatinine < 1.5 mg/dL, Albumin > 0.75 times normal
• No seizures within the past 2 weeks
• No known history of disorders of urea metabolism
• No other malignancy within the past 3 years except non-melanoma skin cancer or cervical cancer
• No clinically significant unrelated systemic illness that would preclude study participation
• No insulin-dependent diabetes

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Study Outline:

• Patients undergo external beam radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-45 (6 ½ weeks)
• Patients also receive oral valproic acid twice daily on days -7 to 49 and oral temozolomide once daily on days 1-49
• Beginning 4 weeks post-radiotherapy, patients receive oral temozolomide alone on days 1-5 as adjuvant therapy
• Adjuvant treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
• After completion of study treatment, patients are followed at 1 month, every 3 months for 2 years, and then every 6 months for 1 year

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/11/12
Updated: 2/24/12