drugset / Trial / NCT04544007
A Phase II Trial of Poly-ICLC for Low-Grade Gliomas
Phase 2
Terminated
3 enrolled
University of Alabama at Birmingham
Children's Healthcare of Atlanta · collabChildren's Hospital Los Angeles · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-02-08
- Primary completion
- 2024-01-04
- Completion
- 2024-11-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hiltonol | Other / unclassified | 20 ug/kg | Intramuscular |