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NCT04576117 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma
A Phase 3 study of Recurrent WHO Grade 2 Glioma and Recurrent Low Grade Astrocytoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT04576117: Active Phase 3 study of Recurrent WHO Grade 2 Glioma and Recurrent Low Grade Astrocytoma, sponsored by National Cancer Institute (NCI).
NCT04576117 is a Phase 3 study of Recurrent WHO Grade 2 Glioma and Recurrent Low Grade Astrocytoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04576117, a Phase 3 study of Recurrent WHO Grade 2 Glioma and Recurrent Low Grade Astrocytoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.
Primary Outcome
The MTD is empirically defined as the highest dose level at which 6 patients have been treated with at most one patient experiencing a dose-limiting toxicity and the next higher dose level has been determined to be too toxic.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- PROCEDURE Magnetic Resonance Imaging
- OTHER Questionnaire Administration
- DRUG Selumetinib Sulfate
Study Locations (20)
Florida
- Golisano Children's Hospital of Southwest Florida - Fort Myers
- UF Health Cancer Institute - Gainesville - Gainesville
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital - Hollywood
- Nemours Children's Clinic-Jacksonville - Jacksonville
- Arnold Palmer Hospital for Children - Orlando
- Nemours Children's Hospital - Orlando
- Johns Hopkins All Children's Hospital - St. Petersburg
- Saint Joseph's Hospital/Children's Hospital-Tampa - Tampa
California
- Loma Linda University Medical Center - Loma Linda
- Children's Hospital Los Angeles - Los Angeles
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale University - New Haven
Alabama
- Children's Hospital of Alabama - Birmingham
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Alfred I duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2021-02-16 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 3 |
What the registry record for NCT04576117 still lists
NCT04576117 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 5 conditions, with Recurrent WHO Grade 2 Glioma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04576117 names 20 study sites across 8 states, led by Florida, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT04576117 about?
NCT04576117 is a clinical study titled "A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma". This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior...
What is the current status of trial NCT04576117?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2021-02-16. Estimated completion is 2026-12-30.
What conditions does trial NCT04576117 study?
This clinical trial studies the following conditions: Recurrent WHO Grade 2 Glioma, Recurrent Low Grade Astrocytoma, Refractory Low Grade Astrocytoma, Refractory Low Grade Glioma, Refractory WHO Grade 1 Glioma.
What interventions are being tested in trial NCT04576117?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Magnetic Resonance Imaging (PROCEDURE), Questionnaire Administration (OTHER), Selumetinib Sulfate (DRUG).
Who is sponsoring clinical trial NCT04576117?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04576117 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04576117's enrollment target sits among peer trials
300 1122nd of 2000 higher than 840 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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