Temozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of temozolomide plus lomustine followed by radiation therapy in treating patients who have high-grade malignant glioma.
Central Nervous System Tumor
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Temozolomide and CCNU in Pediatric Patients With Newly Diagnosed Incompletely Resected Non-Brainstem High-Grade Gliomas|
- Progression Free Survival [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]This trial is a phase I evaluation of temozolomide in combination with a fixed dose of CCNU with the starting dose for temozolomide
|Study Start Date:||November 2000|
|Study Completion Date:||September 2006|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
|Experimental: Pre and Post radiation Chemotherapy||Drug: lomustine Drug: temozolomide|
- Determine the maximum tolerated dose of temozolomide when administered with lomustine in patients with high-grade malignant gliomas.
- Determine the dose-limiting toxic effects of this regimen in these patients.
- Evaluate the feasibility of radiotherapy after this treatment regimen in this patient population.
- Evaluate the radiographic responses in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of temozolomide.
Patients receive oral temozolomide on days 1-5 and oral lomustine on day 1. Treatment continues every 28 days, if blood counts have recovered, for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo radiotherapy on days 1-5 weekly for 6 weeks. Patients continue the same chemotherapy regimen for up to 6 more courses beginning 4 weeks after completion of radiotherapy.
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.