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DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma
NCT04696029 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04696029
The ClinicalTrials.gov registry entry for NCT04696029 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Giselle Sholler, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04696029 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, California, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04696029?
The interventions under investigation include: Difluoromethylornithine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04696029?
This trial is sponsored by Giselle Sholler, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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