NCT00058123

Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma

A Phase II Trial of Poly ICLC in Patients With Recurrent Anaplastic Glioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (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. PURPOSE: This phase II trial is studying how poly-ICLC works in treating patients with recurrent, progressive, or relapsed anaplastic glioma.

Detailed description

OBJECTIVES: * Determine the objective response rate in patients with recurrent or progressive anaplastic glioma treated with poly ICLC. * Determine the efficacy of this drug, in terms of 6-month progression-free survival, in these patients. * Determine the safety profile of this drug in these patients. * Determine the survival of patients treated with this drug. * Determine the tumor response rate in patients treated with this drug. * Determine the biological effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive poly ICLC intramuscularly 3 times a week for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	poly ICLC

Timeline

• Start date: 2003-03-07
• Primary completion: 2007-10-06
• Completion: 2009-01-02
• First posted: 2003-04-09
• Last updated: 2018-08-21
• Results posted: 2018-08-21

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study