Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age0-50
SponsorMilton S. Hershey Medical Center
About this trial
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 criteria
Qualifiers
Participants must be ≤50 years of age at enrollment.
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.
Disqualifiers
BSA of <0.25 m2
Participants with current CNS disease.
Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.
Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.
Trial design
Treatments tested in this trial
- Eflornithine
- Topotecan
- Cyclophosphamide
- Vincristine
- Doxorubicin
- Ifosfamide
- Etoposide
- Cisplatin
- Methotrexate
Treatment groups
406 Participants
are divided into 5 treatment groupsSponsors and collaborators
Milton S. Hershey Medical Center
Lead sponsor
USWM, LLC (dba US WorldMeds)
Collaborator
Source ClinicalTrials.gov