A Phase I Trial of Hypofraction Radiotherapy + Temozolomide in the Treatment of Patients With Glioblastoma Multiforme and Anaplastic Astrocytoma of the Brain
- To determine the maximum tolerated dose of temozolomide when given in combination with
hypofractionated intensity-modulated conformal stereotactic radiotherapy in patients
with newly diagnosed de novo glioblastoma multiforme or anaplastic astrocytoma.
- To determine the time to neuroradiological evidence of tumor recurrence or progression
in patients treated with this regimen.
- To determine the survival time of patients treated with this regimen.
- To determine the time spent in a Karnofsky performance status of 60-100%.
OUTLINE: This is a dose-escalation study of temozolomide.
Beginning 1-3 weeks following surgery or biopsy, patients receive oral temozolomide once
daily for 5 weeks. Beginning 1 week after starting temozolomide, patients also undergo
hypofractionated intensity-modulated conformal stereotactic radiotherapy once daily 5 days a
week for 3 weeks.
After completion of study treatment, patients are followed at 1 month, 2 months, and 3
months, and then every 3 months thereafter.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of temozolomide
Mario Ammirati, MD
Ohio State University Comprehensive Cancer Center
United States: Institutional Review Board
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|