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Tracking Information | |||||
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First Received Date † | December 20, 2005 | ||||
Last Updated Date | April 30, 2009 | ||||
Start Date † | December 2005 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00268385 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas | ||||
Official Title † | Phase I Study of Vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in Combination With Temozolomide in Patients With Malignant Gliomas | ||||
Brief Summary | 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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
Exploratory
OUTLINE: This is a 2-part, multicenter, dose-escalation study of vorinostat.
Beginning in course 2, some patients may receive a higher dose of temozolomide. Treatment may continue beyond 13 courses at the discretion of the investigator. 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. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment | ||||
Condition † | Brain and Central Nervous System Tumors | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 77 | ||||
Completion Date | |||||
Estimated Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00268385 | ||||
Responsible Party | |||||
Secondary IDs †† | ABTC-0403, NABTC-0403 | ||||
Study Sponsor † | Adult Brain Tumor Consortium | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | November 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |