Phase 2Recruiting
Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma
A Phase II Open Label Basket Trial Study Using Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma
- Sponsor
- Milton S. Hershey Medical Center (Academic or other)
- Enrolment
- 406 planned
- Conditions
- Osteosarcoma; Ewing Sarcoma
- Interventions
- Eflornithine; Topotecan; Cyclophosphamide; Vincristine; Doxorubicin; Ifosfamide; Etoposide; Cisplatin; Methotrexate
- Ages
- children, adults
- Registry
- NCT07321912
From the registry
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.
Primary outcomes
- Number of Cohort 1 participants with relapse free survival (RFS) during study
- Number of Cohort 2 participants with event-free survival (EFS) during study
- Cohort 3: Number of Cohort 3 participants at 12 months with disease control
- Cohort 4A: Number of Cohort 4A participants with event-free survival (EFS) during study