Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00058123|
Recruitment Status : Completed
First Posted : April 9, 2003
Results First Posted : August 21, 2018
Last Update Posted : August 21, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: poly ICLC||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Poly ICLC in Patients With Recurrent Anaplastic Glioma|
|Actual Study Start Date :||March 7, 2003|
|Actual Primary Completion Date :||October 6, 2007|
|Actual Study Completion Date :||January 2, 2009|
Experimental: Poly-ICLC Recurrent gliomas
Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)
Drug: poly ICLC
- Proportion of Participants With Objective Response Rate (ORR) [ Time Frame: 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 [ Time Frame: 6 months ]Participants evaluated from date of study entry to the 6 month scan for progression
- Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas [ Time Frame: 2 years ]Toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
- Overall Survival [ Time Frame: 2 years ]based on date of study entry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00058123
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Pennsylvania|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78284-6220|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-6164|
|Study Chair:||Susan M. Chang, MD||University of California, San Francisco|