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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
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
Proportion of Participants With Objective Response Rate (ORR)
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
Time frame: 2 years
Percentage of Participants With Progression Free Survival
Participants evaluated from date of study entry to the 6 month scan for progression
Time frame: 6 months
Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas
Toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: 2 years
Overall Survival
based on date of study entry
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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