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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: | NCT00045110 |
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase I/II trial to study the effectiveness of erlotinib in treating patients who have recurrent malignant glioma or recurrent or progressive meningioma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: erlotinib hydrochloride |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Trial Of OSI-774 In Patients With Recurrent Malignant Gliomas And Malignant Gliomas Post Radiation Therapy |
Study Start Date: | August 2002 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to study phase (I vs II), concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no), histology (recurrent GBM vs recurrent anaplastic glioma vs recurrent meningioma vs stable GBM), preoperative candidacy (yes vs no), and concurrent steroids (yes vs no).
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: Approximately 36 patients will be accrued for the phase I portion of this study within 1 year. Approximately 117-122 patients (32 recurrent glioblastoma multiforme [GBM], 20 recurrent anaplastic gliomas, 55 stable post-radiotherapy GBM, and 10-15 recurrent meningioma) will be accrued for the phase II portion of this study within 15 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Histologically confirmed intracranial malignant glioma
Progressive disease or tumor recurrence on MRI or CT scan
Patients with progressive disease must have failed prior radiotherapy* that was completed at least 4 weeks ago
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Ophthalmic
None of the following ophthalmic abnormalities:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095 | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94143 | |
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 | |
M.D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 | |
Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas | |
Dallas, Texas, United States, 75390-9154 | |
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 |
Principal Investigator: | Lauren E. Abrey, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Lisa M. DeAngelis, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000256358, NABTC-0103, NCI-03-C-0114 |
Study First Received: | September 6, 2002 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00045110 |
Health Authority: | United States: Federal Government |
adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult glioblastoma adult mixed glioma recurrent adult brain tumor |
adult grade III meningioma adult giant cell glioblastoma adult gliosarcoma adult grade I meningioma adult grade II meningioma |
Erlotinib Glioblastoma Meningeal Neoplasms Astrocytoma Central Nervous System Neoplasms Recurrence Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma Meningioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Nervous System Diseases Neoplasms, Nerve Tissue |
Neoplasms, Vascular Tissue Enzyme Inhibitors Neoplasms, Neuroepithelial Protein Kinase Inhibitors Pharmacologic Actions |