Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (Poly-ICLC)
RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining biological therapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining poly-ICLC with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II Trial Of Poly-ICLC For Glioblastoma|
- Overall Survival in Pts With Newly Diagnosed GBM [ Time Frame: total survival from surgical diagnosis ]Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM
- To Determine 6 Months Progression Free Survival [ Time Frame: 6 months ]Patients evaluated from date of diagnosis to the 6 month scan
- Determine the 12-month Survival Rate [ Time Frame: 1 year ]12-month survival rate calculated from date of diagnosis
- to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients [ Time Frame: 2 years ]CTCAE 4
- To Determine the Change in Neurological Status in Patients With Glioblastoma Treated With External Beam Radiotherapy and Poly-ICLC [ Time Frame: 1 year ]This was to be a descriptive measure per investigator, however, due to the reports of premature discontinuation of study agent in response to what turned out to be pseudo-progression, that outcome was not assessed.
- To Determine Tumor Response [ Time Frame: 2 years ]Due to the reports of transient enlargement of contrast enhancing disease with subsequent shrinkage during Poly-ICLC treatment and the lack of central radiological review, the protocol defined criteria for radiological response could not be employed because of the risk of inconsistent results
|Study Start Date:||November 2002|
|Study Completion Date:||December 2009|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Experimental: poly-ICLC Newly diagnosed GBM
Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy
|Drug: poly ICLC|
- 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 unacceptable toxicity.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052715
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Michael Prados, MD||University of California, San Francisco|