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Terminated Phase 2 Interventional Results available

A Phase II Trial of Poly-ICLC for Low-Grade Gliomas

ClinicalTrials.gov ID: NCT04544007

Public ClinicalTrials.gov record NCT04544007. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 5:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04544007
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Enrollment
3 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Up to 22 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 7, 2022
Primary completion
Jan 3, 2024
Completion
Nov 14, 2024
Last update posted
Mar 20, 2025

2022 – 2024

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
The University of Alabama at Birmingham (Site 700) Birmingham Alabama 35294
Children's Hospital of Los Angeles Los Angeles California 90027
Children's National Medical Center (Site 775) Washington D.C. District of Columbia 20010
Children's Healthcare of Atlanta Atlanta Georgia 30342
Children's Lurie Hospital Chicago Illinois 60611
Lurie Children's Hospital of Chicago (Site 350) Chicago Illinois 60611
University of Chicago (Site 850) Chicago Illinois 60637
Washington University - St. Louis (Site 900) St Louis Missouri 63110
New York University Medical Center (Site 200) New York New York 10016
Cincinnati Children's Hospital Medical Center (Site 800) Cincinnati Ohio 45229-3039
Children's Hospital of Philadelphia (Site 750) Philadelphia Pennsylvania 19096
Childrens Medical Center - Univ. of Texas SW (Site 917) Dallas Texas 75235

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04544007, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 20, 2025 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04544007 live on ClinicalTrials.gov.

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