Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Herbert Irving Comprehensive Cancer Center |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004204 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have recurrent or progressive malignant glioma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: temozolomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas |
Study Start Date: | February 2000 |
OBJECTIVES:
OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma).
Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven recurrent or progressive malignant glioma of one of the following types:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305-5408 | |
United States, Florida | |
Mount Sinai Comprehensive Cancer Center | |
Miami Beach, Florida, United States, 33140 | |
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
Chicago, Illinois, United States, 60611-3013 | |
United States, New York | |
Cancer Center of Albany Medical Center | |
Albany, New York, United States, 12208 | |
Herbert Irving Comprehensive Cancer Center | |
New York, New York, United States, 10032 | |
Nalitt Institute for Cancer And Blood Related Diseases | |
Staten Island, New York, United States, 10305 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
Neurological Clinic | |
Portland, Oregon, United States, 97210 | |
United States, Pennsylvania | |
University of Pennsylvania Cancer Center | |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
United States, Wisconsin | |
Froedtert Memorial Lutheran Hospital | |
Milwaukee, Wisconsin, United States, 53226 |
Study Chair: | Casilda Balmaceda, MD | Herbert Irving Comprehensive Cancer Center |
Study ID Numbers: | CDR0000067449, CPMC-IRB-8622, SPRI-CPMC-IRB-8622 |
Study First Received: | January 21, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004204 |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult anaplastic astrocytoma adult anaplastic oligodendroglioma |
Neuroectodermal Tumors Brain Neoplasms Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma |
Glioma Central Nervous System Neoplasms Temozolomide Recurrence Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Nervous System Diseases Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Pharmacologic Actions |