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
Protocol # 06-C-0112
- Why is this trial important?
- Who is eligible for this trial?
- What types of drugs or therapies are being used?
- What is the treatment plan?
- What is the frequency and duration of the visits?
- What are the costs?
- Who is the Principal Investigator?
- Where is this trial taking place?
- Who are the contacts for this trial?
- Where can additional information be found?
Why is this trial important?
The high rate of recurrence of high-grade gliomas has led to optimization of local therapies. 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.
Who is eligible for this trial? (PDQ)
- 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
What types of drugs or therapies are being used?
This protocol involves the use of valproic acid in combination with temozolomide and radiotherapy for patients with high-grade gliomas.
What is the treatment plan? (PDQ)
- Patients undergo external beam radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-45 (6½ 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
What is the frequency and duration of the visits?
Radiation therapy will be administered daily, Monday through Friday, at NCI's Radiation Oncology Branch. The duration of this treatment is approximately 6 weeks. Follow-up evaluations will occur at 1 month after the completion of therapy, followed by every-3-months intervals for the first 2 year(s), and then every 6 months thereafter for a total of 3 years.
What are the costs?
There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem to help offset the costs of meals and lodging if they are being treated as outpatients.
It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.
No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets the eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.
Who is the Principal Investigator?
Dr. Kevin A. Camphausen received his M.D. from Georgetown University in 1996. He completed his internship at Georgetown in 1997 and a residency in radiation oncology at the Joint Center for Radiation Therapy at Harvard Medical School in 2001. Dr. Camphausen spent the last 2 years of his fellowship working in the laboratory of Dr. Judah Folkman studying the interaction of angiogenesis inhibitors and radiotherapy. He joined NCI in July of 2001.
Where is this trial taking place?
Warren Grant Magnuson Clinical Center
National Institutes of Health
NCI Radiation Oncology Branch
10 Center Drive
Bethesda, Maryland 20892
Who are the contacts for this trial?
Kevin Camphausen, M.D.
Principal Investigator
Phone: 301-496-5457
Referrals:
Sharon 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
Where can additional information be found?
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