Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

NCT07321912 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2026-01-08

No results posted yet for this study

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

Interventions

DRUG

Eflornithine

Oral twice daily

DRUG

Topotecan

IV

DRUG

Vincristine

IV

DRUG

Doxorubicin

IV

DRUG

Ifosfamide

IV

DRUG

Etoposide

IV

DRUG

Cisplatin

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07321912 on ClinicalTrials.gov