Phase II Trial Of Poly-ICLC For Glioblastoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Overall Survival in Pts With Newly Diagnosed GBM
Study Overview
Brief Summary
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.
Detailed Description
OBJECTIVES:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
poly-ICLC Newly diagnosed GBM
Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy
Intramuscular injection
Drug Poly-ICLC
Intervention: poly ICLC (Drug)
Outcomes
Primary Outcomes
Overall Survival in Pts With Newly Diagnosed GBM
Time Frame: 2 years
Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM
Secondary Outcomes
- To Determine 6 Months Progression Free Survival(6 months)
- Determine the 12-month Survival Rate(1 year)
- to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients(2 years)
- To Determine the Change in Neurological Status in Patients With Glioblastoma Treated With External Beam Radiotherapy and Poly-ICLC(1 year)
- To Determine Tumor Response(2 years)