Status:
COMPLETED
Valproic Acid With Temozolomide and Radiation Therapy to Treat Brain Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
High Grade Gliomas
Brain Tumors
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief 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 s...
Detailed Description
BACKGROUND: * 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 demonst...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Histological diagnosis:
- Pathologically confirmed glioblastoma multiforme.
- Histologic diagnosis of glioblastoma multiforme (GBM) will have been established by biopsy or resection no more than 6 weeks prior to enrollment.
- The patient is a candidate for definitive external beam radiotherapy.
- Patients must be older than 18 years with a life expectancy greater than 8 weeks.
- Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Patients must have a primary medical oncologist in the community who is willing to collaborate with the Radiation Oncology Branch (ROB) staff in the clinical management of the patient, specifically in the prescription of Temozolomide and toxicity monitoring in the adjuvant phase.
- Laboratory functions:
- Adequate bone marrow function defined as a peripheral absolute granulocyte count of greater than 1500/mm\^3, hemoglobin greater than 10gm/dL, and platelet count greater than 100,000/mm\^3.
- Adequate liver function, defined as bilirubin and serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) less than 2 x the upper limit of normal.
- Serum creatinine less than 1.5 mg/dl.
- Serum albumin greater than 0.75 x normal.
- All patients or their legal guardian must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study BEFORE any of the protocol related studies are performed (this does not include routine laboratory tests or imaging studies required to establish eligibility).
- Subjects of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.
- EXCLUSION CRITERIA
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00302159
Start Date
March 1 2006
End Date
November 1 2014
Last Update
August 18 2016
Active Locations (3)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6056
3
Virginia Commonwealth University
Richmond, Virginia, United States, 23284