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Sponsors and Collaborators: |
North American Brain Tumor Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00268385 |
RATIONALE: Drugs used in chemotherapy, such as vorinostat and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may help temozolomide work better by making tumor cells more sensitive to the drug. Giving vorinostat together with temozolomide may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with temozolomide in treating patients with malignant gliomas.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: temozolomide Drug: vorinostat |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in Combination With Temozolomide in Patients With Malignant Gliomas |
Estimated Enrollment: | 77 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Exploratory
OUTLINE: This is a 2-part, multicenter, dose-escalation study of vorinostat.
Cohorts of 3-6 patients receive escalating doses of vorinostat during course 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
Cohorts of 3-6 patients receive de-escalating doses of vorinostat (beginning at the MTD determined in part 1) during courses 1 and 2 until the MTD for part 2 is determined. The MTD is defined as in part 1. An additional 6 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 77 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven intracranial malignant glioma, including the following subtypes:
Patients in part 1 of this study must meet the following requirements:
28 days since prior cytotoxic therapy
Patients who have recently undergone resection of recurrent or progressive disease must meet the following conditions:
Patients in part 2 of this study must meet the following requirements:
Stable disease after radiation therapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
Los Angeles, California, United States, 90095-1781 | |
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Patrick Y. Wen, MD 617-632-2166 patrick_wen@dfci.harvard.edu | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Lisa M. DeAngelis, MD 212-639-7997 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: David A. Reardon, MD 919-668-1409 reard003@mc.duke.edu | |
United States, Pennsylvania | |
UPMC Cancer Centers | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792-6164 | |
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 |
Principal Investigator: | Patrick Y. Wen, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000450762, NABTC-0403 |
Study First Received: | December 20, 2005 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00268385 |
Health Authority: | Unspecified |
adult anaplastic oligodendroglioma adult glioblastoma adult gliosarcoma adult mixed glioma |
adult anaplastic astrocytoma adult giant cell glioblastoma recurrent adult brain tumor |
Glioblastoma Astrocytoma Vorinostat Central Nervous System Neoplasms Temozolomide Recurrence Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Anticarcinogenic Agents Anti-Inflammatory Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Nervous System Diseases Enzyme Inhibitors Protective Agents Pharmacologic Actions Neoplasms |
Neoplasms by Site Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antineoplastic Agents, Alkylating Antirheumatic Agents Neoplasms, Neuroepithelial Central Nervous System Agents Alkylating Agents |