NCT00052715

Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Phase II Trial Of Poly-ICLC For Glioblastoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	poly ICLC

Timeline

• Start date: 2002-10-23
• Primary completion: 2006-02-25
• Completion: 2009-01-01
• First posted: 2003-01-27
• Last updated: 2018-07-18
• Results posted: 2017-03-16

Locations

1 site across 1 country: United States