Phase II Study of Temozolomide and Radiation in Newly Diagnosed GBM Patients After Resection and Insertion of Gliadel® Wafers
- Determine the efficacy of adjuvant temozolomide when administered during and after
external beam radiotherapy, in terms of survival, in patients with newly diagnosed
glioblastoma multiforme who have undergone prior total surgical resection and placement
of polifeprosan 20 with carmustine implant (Gliadel® wafers).
OUTLINE: This is an open-label study.
Patients undergo external beam radiotherapy 5 days a week for 6 weeks and concurrently
receive oral temozolomide once daily for 6 weeks. No more than 28 days later, patients
receive additional oral temozolomide once daily on days 1-5. Treatment with temozolomide
repeats every 28 days for up to 6 courses in the absence of disease progression or
After completion of study treatment, patients are followed every 2 months for survival.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 18 months.
Masking: Open Label, Primary Purpose: Treatment
Stuart A. Grossman, MD
Sidney Kimmel Comprehensive Cancer Center
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|