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Sponsors and Collaborators: |
North American Brain Tumor Consortium National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025675 |
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of CNS tumors.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent or progressive CNS tumors.
Condition | Intervention | Phase |
Brain and Central Nervous System Tumors |
Drug: gefitinib |
Phase II |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | ZD1839 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | ZD1839 FOR Treatment Of Recurrent Or Progressive Malignant Astrocytoma Or Glioblastoma And Recurrent Or Progessive Meningioma: A Phase II Study With A Phase I Component For Patients Receiving EIAEDs |
Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no) and disease type (for phase II only) (benign meningioma vs malignant meningioma vs hemangiopericytoma vs glioblastoma vs other anaplastic glioma). (Phase I closed to accrual as of 09/19/2003).
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients (who are receiving EIAEDs) receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A minimum of 30 patients will be accrued for the phase I portion of this study within 10 months . (Phase I closed to accrual as of 09/19/2003). A total of 48 patients will be accrued for the phase II portion of this study within 6-8 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Histologically confirmed supratentorial malignant primary glioma
Histologically confirmed or radiographically defined recurrent or progressive brain or spinal meningioma, including base of skull or cavernous sinus meningiomas
Recurrent or progressive disease by MRI or CT scan
Phase I (closed to accrual as of 09/19/2003):
Phase II:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
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 | |||||
NCI - Neuro-Oncology Branch | |||||
Bethesda, Maryland, United States, 20892-8200 | |||||
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 - 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 |
North American Brain Tumor Consortium |
National Cancer Institute (NCI) |
Study Chair: | Frank S. Lieberman, MD | UPMC Cancer Centers |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068984, NABTC-0001 |
First Received: | October 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00025675 |
Health Authority: | United States: Federal Government |
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