Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004204|
Recruitment Status : Unknown
Verified April 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 18, 2003
Last Update Posted : January 6, 2014
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 or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: temozolomide||Phase 2|
- Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide.
- Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide.
- Determine the toxicity of this regimen in these patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas|
|Study Start Date :||February 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004204
|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|
|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|