Conditions: Brain and Central Nervous System Tumors
Keywords: adult anaplastic astrocytoma adult mixed glioma adult anaplastic oligodendroglioma recurrent adult brain tumor adult anaplastic ependymoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 55
Healthy volunteers: no

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.

Arms:
arm 1: Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)

Intramuscular injection

Drug Poly-ICLC

Interventions: intervention 1: poly ICLC
Intervention descriptions: intervention 1: None

Protocol document: