Brain Tumor Clinical Trial
Official title:
A Phase I Study of Temozolomide and CCNU in Pediatric Patients With Newly Diagnosed Incompletely Resected Non-Brainstem High-Grade Gliomas
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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