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NCT04544007 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial of Poly-ICLC for Low-Grade Gliomas
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT04544007: Clinical Trial Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT04544007 is a Phase 2 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04544007, a Phase 2 study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study 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.
Primary Outcome
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), using Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria. Complete Response (CR) is complete disappearance of the target lesion on T2 weighted and T2 weighted fluid attenuated inversion recovery (FLAIR) imaging and contrast imaging using baseline MRI or best recorded response for comparison; Partial Response (PR) is 50% or greate
Interventions
- DRUG Poly ICLC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-02-08 |
| Est. Completion | 2024-11-15 |
| Phase | Phase 2 |
Why NCT04544007 stopped before completion
NCT04544007 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Poly ICLC is the first listed.
NCT04544007 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04544007 about?
NCT04544007 is a clinical study titled "A Phase II Trial of Poly-ICLC for Low-Grade Gliomas". 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 ...
What is the current status of trial NCT04544007?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2022-02-08. Estimated completion is 2024-11-15.
What interventions are being tested in trial NCT04544007?
The interventions under investigation include: Poly ICLC (DRUG).
Who is sponsoring clinical trial NCT04544007?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04544007's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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