Temozolomide in Treating Patients With Progressive Low-Grade 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: NCT00003466|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 9, 2014
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: temozolomide||Phase 2|
- Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide.
- Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients.
OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma).
Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses.
Patients are followed every 8-12 weeks for 2 years.
PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this study within 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Official Title:||Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal|
|Study Start Date :||March 1998|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||July 2005|
- Response rate
- Activity of temozolomide
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): NCT00003466
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104-4318|
|Study Chair:||Henry S. Friedman, MD||Duke Cancer Institute|