Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma
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
| Condition(s) | Osteosarcoma, Ewing Sarcoma, Ewing Sarcoma Metastatic |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Cohort 1: Inclusion Criteria: 1. Participants must be ≤50 years of age at enrollment. 2. Histologically confirmed Ewing sarcoma that is refractory or in first or subsequent relapse. Histological confirmation either at initial diagnosis or disease progression. * Relapsed: Participants that have achieved CR at any point and then relapsed following/during standard of care therapy. * Refractory: Participants that failed to achieve CR after standard of care therapy or having progressed during standard of care therapy. * Note: Standard of care therapy for Ewing sarcoma includes multi-agent chemotherapy with local control consisting of either surgery and/or radiation therapy. 3. Extent of disease is judged by treating team to be amenable to the delivery of definitive local control (either definit |
| Ages | 0 Years to 50 Years |
| Sex | All |
| Lead sponsor | Milton S. Hershey Medical Center |
| Locations | Tampa, Florida, United States; Hershey, Pennsylvania, United States |
| Start date | 2026-06-05 |
| NCT ID | NCT07321912 |
| Official listing | https://clinicaltrials.gov/study/NCT07321912 |