Phase II Trial Of Poly-ICLC For Glioblastoma
- Determine the efficacy of poly ICLC and radiotherapy, in terms of total survival from
date of diagnosis, in patients with newly diagnosed glioblastoma multiforme.
- Determine the safety and toxicity profile of this regimen in these patients.
- Determine the 12-month survival rate in patients treated with this regimen.
- Assess progression-free survival at 6 months and median progression-free survival from
date of diagnosis of patients treated with this regimen.
- Assess response in patients treated with this regimen.
- Assess changes in neurological status in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Within 1-4 weeks after surgery, patients receive poly ICLC intramuscularly 3 times weekly
(on days 1, 3, and 5). Treatment continues in the absence of disease progression or
One week after the initiation of poly ICLC, patients undergo external beam radiotherapy once
daily 5 days a week for 6 weeks.
Patients are followed monthly for 1 year and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.
Masking: Open Label, Primary Purpose: Treatment
Michael Prados, MD
University of California, San Francisco
United States: Federal Government
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|