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

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Poly-ICLC Recurrent gliomas	poly ICLC	Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday) Intramuscular injection Drug Poly-ICLC

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Objective Response Rate (ORR)	2 years	Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined. Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids. Partial Response (PR): \>/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone. Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). ORR = CR + PR
Percentage of Participants With Progression Free Survival	6 months	Participants evaluated from date of study entry to the 6 month scan for progression

Secondary Outcome Measures

Name	Time	Method
Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas	2 years	Toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Overall Survival	2 years	based on date of study entry

Locations (8): Jonsson Comprehensive Cancer Center at UCLA
🇺🇸
Los Angeles, California, United States
UCSF Comprehensive Cancer Center
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San Francisco, California, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
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New York, New York, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
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Pittsburgh, Pennsylvania, United States
M.D. Anderson Cancer Center at University of Texas
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Houston, Texas, United States
University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States
University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, United States