🏛️ Verified NIH Record • Updated 2026-08-10
DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma (NCT04696029)
🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Giselle Sholler
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (23 items) and avoid the listed exclusions (8 items).
Location: Arkansas Children's Hospital — Little Rock, Arkansas
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- BSA of \<0.25 m2
- Metastatic disease outside of CNS
- Relapsed/refractory patients who are radiation-naïve and age 5 years or older at time of enrollment
- Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
- Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.
- Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
- Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (26 Sites)
- Arkansas Children's Hospital — Little Rock, Arkansas
- UCSF Benioff Children's Hospital Oakland — Oakland, California
- UC Davis Comprehensive Cancer Center — Sacramento, California
- Rady Children's Hospital — San Diego, California
- Stanford University — Stanford, California
- Connecticut Children's Hospital — Hartford, Connecticut
- Nicklaus Children's Hospital — Miami, Florida
- Arnold Palmer Hospital for Children — Orlando, Florida
- All Children's Hospital Johns Hopkins Medicine — St. Petersburg, Florida
- St. Joseph's Children's Hospital — Tampa, Florida
- Kapiolani Medical Center for Women and Children — Honolulu, Hawaii
- Advocate Aurora Research Institute — Chicago, Illinois
- Kentucky Children's Hospital — Lexington, Kentucky
- Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine — Louisville, Kentucky
- Children's Mercy Hospitals and Clinics — Kansas City, Missouri
- Cardinal Glennon Children's Medical Center — St Louis, Missouri
- Hackensack University Medical Center — Hackensack, New Jersey
- Levine Children's Hospital — Charlotte, North Carolina
- Duke University — Durham, North Carolina
- University of Oklahoma — Oklahoma City, Oklahoma
- Randall Children's Hospital — Portland, Oregon
- Penn State Milton S. Hershey Medical Center and Children's Hospital — Hershey, Pennsylvania
- Hasbro Children's Hospital — Providence, Rhode Island
- Medical University of South Carolina — Charleston, South Carolina
- Dell Children's Blood and Cancer Center — Austin, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.