A Phase II Open Label Basket Trial Study Using Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma
Milton S. Hershey Medical Center
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.
Eligibility
- Age range
- 0–50 years
- Sex
- All
- Healthy volunteers
- No
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-age…
Interventions
- DrugEflornithine
Oral twice daily
- DrugTopotecan
IV
- DrugCyclophosphamide
IV
- DrugVincristine
IV
- DrugDoxorubicin
IV
- DrugIfosfamide
IV
- DrugEtoposide
IV
- Drug
Locations (2)
- St. Joseph's Children's HospitalTampa, Florida
- Penn State Milton S. Hershey Medical Center and Children's HospitalHershey, Pennsylvania