NCT00006024

Temozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma

A Phase I Study of Temozolomide and CCNU in Pediatric Patients With Newly Diagnosed Incompletely Resected Non-Brainstem High-Grade Gliomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 3 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Brain Tumor
• Central Nervous System Tumor

Interventions

Type	Name	Description
DRUG	lomustine
DRUG	temozolomide

Timeline

• Start date: 2000-11-01
• Primary completion: 2005-01-01
• Completion: 2006-09-01
• First posted: 2003-01-27
• Last updated: 2014-02-13

Locations

235 sites across 7 countries: United States, Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland