Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal
OBJECTIVES:
- 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.
Interventional
Primary Purpose: Treatment
Response rate
No
Henry S. Friedman, MD
Study Chair
Duke Cancer Institute
United States: Federal Government
1703 (CDR0000066502)
NCT00003466
March 1998
July 2005
Name | Location |
---|---|
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |