Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase II Trial of Poly ICLC in Patients With Recurrent Anaplastic Glioma
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.
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.
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