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Brief Title: Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma
Official Title: A Phase II Trial of Poly ICLC in Patients With Recurrent Anaplastic Glioma
Study ID: NCT00058123
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
M.D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Name: Susan M. Chang, MD
Affiliation: University of California, San Francisco
Role: STUDY_CHAIR