A Phase II Trial of Poly ICLC in Patients With Recurrent Anaplastic Glioma
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression within 6 months
continous, 6 months
No
Susan M. Chang, MD
Study Chair
University of California, San Francisco
United States: Food and Drug Administration
ABTC-0106 CDR0000287012
NCT00058123
March 2003
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |