Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma
NCT07321912 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 406
Last updated 2026-01-08
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
- DRUG
-
Eflornithine
Oral twice daily
- DRUG
-
Topotecan
IV
- DRUG
-
IV
- DRUG
-
Vincristine
IV
- DRUG
-
Doxorubicin
IV
- DRUG
-
Ifosfamide
IV
- DRUG
-
Etoposide
IV
- DRUG
-
IV
- DRUG
-
Methotrexate
IV
Sponsors & Collaborators
-
USWM, LLC (dba US WorldMeds)
collaborator INDUSTRY -
Milton S. Hershey Medical Center
lead OTHER
Principal Investigators
-
Giselle SaulnierSholler, MD · Penn State Health Children's Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 0 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2031-04-01
- Completion
- 2036-04-01
- FDA Drug
- Yes
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