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Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 2 to 3
    • Eligibility criteria expanded, about 130 words
  2. Re-verified, no change to tracked fieldsv5
  3. Primary completion pushed from Apr 1, 2031 to Jun 1, 2031
    • Study completion pushed from Apr 1, 2036 to Jun 1, 2036
    • Study sites: 1 to 2
    • Start date changed from estimate of May 21, 2026 to Jun 5, 2026
    v4
  4. Recruitment opened
    • Start date: Apr 1, 2026 to May 21, 2026
    • Study sites: 0 to 1
    v3
  5. Interventions: Eflornithine (Drug) to Cisplatin (Drug), Cyclophosphamide (Drug), Doxorubicin (Drug), Eflornithine (Drug), Etoposide (Drug), Ifosfamide (Drug), Methotrexate…v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ewing sarcoma (EWS) and osteosarcoma primarily affect adolescents and young adults. Common treatments include chemotherapy, surgery and radiation, however, there have been few recent advancements in the standard of care. By incorporating eflornithine (DFMO) as an additional therapy and/or maintenance therapy we hope to safely observe improved event-free survival and overall survival. There are 5 cohorts covered under this master protocol.
Trial Details
NCT Number NCT07321912
Lead Sponsor Milton S. Hershey Medical Center
Collaborators: USWM, LLC (dba US WorldMeds)
Conditions
(from sponsor)		 Osteosarcoma, Ewing Sarcoma
Related terms Osteosarcoma, Sarcoma, Ewing
Enrollment 406 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov