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NCT04696029 · ClinicalTrials.gov registry record · Phase 2
DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma
A Phase 2 study of Medulloblastoma, sponsored by Giselle Sholler.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
- 20
- Study locations
NCT04696029: Recruiting Phase 2 study of Medulloblastoma, sponsored by Giselle Sholler.
NCT04696029 is a Phase 2 study of Medulloblastoma that is actively recruiting participants, run by Giselle Sholler. The registered enrollment target is 118 participants, below the 137-participant average among 29 other Medulloblastoma trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04696029, a Phase 2 study of Medulloblastoma, is actively recruiting participants, sponsored by Giselle Sholler.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
- 20
- Study locations
Study Summary
Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma.
Primary Outcome
o To evaluate the efficacy of difluoromethylornithine (DFMO) as a single agent in preventing relapse in patients with molecular high risk and very high risk medulloblastoma, and relapsed/refractory medulloblastoma based upon the 2-year progression-free survival rate (PFS) compared to relevant historical controls.
Conditions Studied
Interventions
- DRUG Difluoromethylornithine
Study Locations (20)
Florida
- Nicklaus Children's Hospital - Miami
- Arnold Palmer Hospital for Children - Orlando
- All Children's Hospital Johns Hopkins Medicine - St. Petersburg
- St. Joseph's Children's Hospital - Tampa
California
- UCSF Benioff Children's Hospital Oakland - Oakland
- Rady Children's Hospital - San Diego
- Stanford University - Stanford
Kentucky
- Kentucky Children's Hospital - Lexington
- Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine - Louisville
Missouri
- Children's Mercy Hospitals and Clinics - Kansas City
- Cardinal Glennon Children's Medical Center - St Louis
Arkansas
- Arkansas Children's Hospital - Little Rock
Connecticut
- Connecticut Children's Hospital - Hartford
Hawaii
- Kapiolani Medical Center for Women and Children - Honolulu
Illinois
- Advocate Aurora Research Institute - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2021-03-29 |
| Est. Completion | 2029-03 |
| Phase | Phase 2 |
What NCT04696029 shows while recruiting
NCT04696029 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 137-participant average among 29 other Medulloblastoma trials with a reported enrollment target (14% lower).
The record links to 1 condition, with Medulloblastoma appearing as the primary indexed condition, and to 1 intervention - of which Difluoromethylornithine is the first listed.
NCT04696029 names 20 study sites across 13 states, led by Florida, California, Kentucky.
Frequently Asked Questions
What is clinical trial NCT04696029 about?
NCT04696029 is a clinical study titled "DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma". Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma.
What is the current status of trial NCT04696029?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2021-03-29. Estimated completion is 2029-03.
What conditions does trial NCT04696029 study?
This clinical trial studies the following conditions: Medulloblastoma.
What interventions are being tested in trial NCT04696029?
The interventions under investigation include: Difluoromethylornithine (DRUG).
Who is sponsoring clinical trial NCT04696029?
This trial is sponsored by Giselle Sholler, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04696029 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Medulloblastoma
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 NCT04696029's enrollment target sits among peer trials
118 13th of 29 higher than 17 of 29 other Medulloblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Medulloblastoma 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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