Spots Global Cancer Trial Database for A Phase II Trial of Poly-ICLC for Low-Grade Gliomas
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Trial Identification
Brief Title: A Phase II Trial of Poly-ICLC for Low-Grade Gliomas
Official Title: A Phase II Trial of Poly-ICLC for Progressive, Previously Treated Low-Grade Gliomas in Children and Young Adults With Neurofibromatosis Type 1
Study ID: NCT04544007
Interventions
Study Description
Brief Summary: This is a phase II, prospective, longitudinal, multi-center trial of poly-ICLC (Hiltonol ®) treatment for progressive low-grade gliomas in pediatric patients with NF1. The primary objective is to evaluate the efficacy of poly-ICLC in pediatric NF1 patients with progressive low-grade glioma (LGG) as measured by objective tumor response rate (CR+PR) within the first 48 weeks (12 cycles) of therapy. There will also be secondary and exploratory objectives listed in the detailed description below.
Detailed Description: This is a phase II, prospective, longitudinal, multi-center trial of poly-ICLC (Hiltonol ®) treatment for progressive low-grade gliomas in pediatric patients with NF1. The primary objective is to evaluate the efficacy of poly-ICLC in pediatric NF1 patients with progressive low-grade glioma (LGG) as measured by objective tumor response rate (CR+PR) within the first 48 weeks (12 cycles) of therapy. The secondary objectives are to: 1. Determine 12, 24 and 60 month progression free survival (PFS) in pediatric NF1 patients with progressive LGG treated with poly-ICLC. 2. Evaluate the efficacy of poly-ICLC in pediatric NF1 patients with progressive LGG as measured by best objective tumor response rate (CR+PR) within 24 cycles of therapy. 3. Evaluate the efficacy of poly-ICLC in pediatric NF1 patients with progressive LGG as measured by clinical benefit response rate (CR+PR+MR+SD) after 12 and 24 cycles of therapy. 4. Assess the toxicity associated with poly-ICLC treatment in pediatric NF1 patients with LGG. Exploratory objectives are to: 1. Evaluate the visual outcome measures in children with progressive optic pathway gliomas treated with poly-ICLC. Visual response is defined as 0.2 logMAR or greater in acuity improvement. 2. Evaluate patient reported outcomes and quality of life measures. 3. Evaluate biological correlates.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Alabama at Birmingham (Site 700), Birmingham, Alabama, United States
Children's Hospital of Los Angeles, Los Angeles, California, United States
Children's National Medical Center (Site 775), Washington, District of Columbia, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
Children's Lurie Hospital, Chicago, Illinois, United States
Lurie Children's Hospital of Chicago (Site 350), Chicago, Illinois, United States
University of Chicago (Site 850), Chicago, Illinois, United States
Washington University - St. Louis (Site 900), Saint Louis, Missouri, United States
New York University Medical Center (Site 200), New York, New York, United States
Cincinnati Children's Hospital Medical Center (Site 800), Cincinnati, Ohio, United States
Children's Hospital of Philadelphia (Site 750), Philadelphia, Pennsylvania, United States
Childrens Medical Center - Univ. of Texas SW (Site 917), Dallas, Texas, United States
Contact Details
Name: Juliette Southworth, BS, CCRP
Affiliation: University of Alabama at Birmingham, NFCTC
Role: STUDY_DIRECTOR
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