A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme
- Determine the response rate of patients with glioblastoma multiforme treated with
thalidomide and irinotecan after radiotherapy.
- Determine the preliminary efficacy of this regimen in these patients.
- Determine the disease-free survival and overall survival of patients treated with this
- Determine the toxicity of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: Beginning 2-4 weeks after completion of radiotherapy, patients receive irinotecan
IV over 90 minutes on day 1. Patients also receive oral thalidomide daily. Treatment repeats
every 21 days for at least 3 courses in the absence of disease progression or unacceptable
Quality of life is assessed at baseline, 1 week after the first course, prior to all
subsequent courses, and then after course 6.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the response rate and hence preliminary efficacy of Irinotecan and Thalidomide following radiotherapy in the treatment of newly diagnosed or relapsed glioblastoma multiforme.
Camilo E. Fadul, MD
Norris Cotton Cancer Center
United States: Federal Government
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University||Columbus, Ohio 43210-1240|