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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: | NCT00010049 |
RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for recurrent glioma and meningioma.
PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, recurrent, or unresectable malignant glioma or meningioma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: imatinib mesylate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Trial of STI571 (NSC 716051) in Patients With Recurrent Malignant Gliomas |
Study Start Date: | November 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to concurrent enzyme-inducing anti-epileptic drug use (yes [stratum closed to accrual as of 05/15/2003 for phase I and phase II] vs no).
Cohorts of 3-6 patients receive escalating doses of STI571 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.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of the study within 6 months and a total of 39 patients will be accrued for phase II of the study within 6-8 months. (Glioblastoma multiforme patients excluded from phase II as of 05/13/2003).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent or unresectable malignant glioma
Progressive or recurrent disease by MRI or CT scan and/or resection
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Phase I only:
Phase II only:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94143-0128 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48109-0316 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Pennsylvania | |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, Texas | |
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
Dallas, Texas, United States, 75390-9154 | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78284-6220 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792 |
Study Chair: | Patrick Y. Wen, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000068437, NABTC-9908, NCI-01-C-0243, UCLA-0101024 |
Study First Received: | February 2, 2001 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00010049 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult meningioma adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult mixed glioma |
adult pilocytic astrocytoma adult subependymoma adult grade III meningioma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Meningeal Neoplasms Astrocytoma Central Nervous System Neoplasms Protein Kinase Inhibitors Recurrence Imatinib Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma Meningioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Meningeal Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Neoplasms, Nerve Tissue Enzyme Inhibitors Central Nervous System Neoplasms Protein Kinase Inhibitors Pharmacologic Actions Imatinib |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Neoplasms, Vascular Tissue Meningioma Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |