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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00302159 |
Purpose
Background:
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:
| Condition | Intervention | Phase |
|---|---|---|
|
High Grade Gliomas Brain Tumors |
Procedure: adjuvant therapy Drug: Temozolomide Drug: Valporic Acid Radiation: Radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 41 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
BACKGROUND:
OBJECTIVES:
-The primary measure of efficacy will be progression free survival and overall survival.
ELIGIBILITY:
DESIGN:
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Histological diagnosis:
Pathologically confirmed glioblastoma multiforme.
Histologic diagnosis of 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 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 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 SGOT/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.
Contacts and Locations| Contact: NCI Referral Office | 1-888-NCI-1937 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Sub-Investigator: National Cancer Institute Referral Office For more information at the NIH Clinical Center contact | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104-6056 | |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23284 | |
More Information
| Responsible Party: | Kevin A. Camphausen, M.D./National Cancer Institute, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT00302159 History of Changes |
| Obsolete Identifiers: | NCT00313664 |
| Other Study ID Numbers: | 060112, 06-C-0112 |
| Study First Received: | March 11, 2006 |
| Last Updated: | December 29, 2011 |
| Health Authority: | United States: Federal Government |
|
Chemotherapy Radiation Brain Tumor GBM |
Radiosensitizer Glioblastoma Glioblastoma Multiforme |
|
Brain Neoplasms Glioma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Valproic Acid Temozolomide Histone Deacetylase Inhibitors Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants |