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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045708 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone and how well it works in treating patients with recurrent glioma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: ixabepilone |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Trial of BMS-247550 for Treatment of Patients With Recurrent High-Grade Gliomas |
Study Start Date: | October 2002 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a phase I, dose-escalation, multicenter study followed by a phase II, safety and efficacy, multicenter study. For phase I only, patients are stratified according to cytochrome P450-inducing anticonvulsant use (yes vs no).
Patients are followed every 2 months.
PROJECTED ACCRUAL: A minimum of 10-15 patients will be accrued for the phase I portion of this study. A total of 22-33 patients will be accrued for the phase II portion of this study within 4-6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant glioma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent moderate to significant inhibitors of CYP3A4, including any of the following:
United States, Alabama | |
Comprehensive Cancer Center at University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
Tampa, Florida, United States, 33612-9497 | |
United States, Georgia | |
Winship Cancer Institute of Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231 | |
United States, Massachusetts | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114-2617 | |
United States, Michigan | |
Josephine Ford Cancer Center at Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, North Carolina | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1030 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 |
Study Chair: | David M. Peereboom, MD | The Cleveland Clinic |
Study ID Numbers: | CDR0000257118, NABTT-2111, JHOC-NABTT-2111 |
Study First Received: | September 6, 2002 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00045708 History of Changes |
Health Authority: | United States: Federal Government |
adult anaplastic astrocytoma adult glioblastoma recurrent adult brain tumor adult anaplastic oligodendroglioma |
adult mixed glioma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Epothilones Antimitotic Agents Central Nervous System Neoplasms Recurrence Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Tubulin Modulators Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Epothilones Mitosis Modulators Neoplasms, Nerve Tissue Nervous System Diseases Antimitotic Agents Central Nervous System Neoplasms Pharmacologic Actions |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Tubulin Modulators Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |