NCT07321912

Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

A Phase II Open Label Basket Trial Study Using Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 406 (estimated)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 0 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteosarcoma
• Ewing Sarcoma
• Ewing Sarcoma Metastatic

Interventions

Type	Name	Description
DRUG	Eflornithine	Oral twice daily
DRUG	Topotecan	IV
DRUG	Cyclophosphamide	IV
DRUG	Vincristine	IV
DRUG	Doxorubicin	IV
DRUG	Ifosfamide	IV
DRUG	Etoposide	IV
DRUG	Cisplatin	IV
DRUG	Methotrexate	IV

Timeline

• Start date: 2026-04-01
• Primary completion: 2031-04-01
• Completion: 2036-04-01
• First posted: 2026-01-07
• Last updated: 2026-01-08

Regulatory

• FDA-regulated drug study