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Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

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

NCT07321912•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

0 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Cohort 1:
•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-agent chemotherapy with local control consisting of either surgery and/or radiation therapy.
•3. Extent of disease is judged by treating team to be amenable to the delivery of definitive local control (either definitive radiation, surgery, or a combination of these) at the time of study enrollment (to be completed after protocol defined Cycle 2).
•4. Participants may enroll anytime during Cycle 1 or 2, prior to local control, as long as they received the same treatment during Cycle 1 and 2 as prescribed in this protocol.
•5. Relapsed or refractory disease, including at least one of the following:
•* Tumor by CT or MRI
+116 more criteria

Exclusion Criteria

•1. BSA of \<0.25 m2
•2. Participants with current CNS disease.
•3. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.
•6. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.
•Cohort 2:
•1. BSA of \<0.25 m2
•2. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.
•4. Participants with regional node involvement as their only site of disease beyond the primary tumor.
•5. Participants whose primary tumors arise in the intra-dural soft tissue (e.g. brain and spinal cord).
•6. Participants with current CNS disease
+14 more criteria

Key Dates

Start Date

April 1, 2026

Primary Completion Date

April 1, 2031

Completion Date

April 1, 2036

Last Updated

January 8, 2026

Enrollment

406

ESTIMATED participants

Conditions

OsteosarcomaEwing SarcomaEwing Sarcoma Metastatic

Interventions

Eflornithine

DRUG

Topotecan

DRUG

Cyclophosphamide

DRUG

Vincristine

DRUG

Doxorubicin

DRUG

Ifosfamide

DRUG

Etoposide

DRUG

Cisplatin

DRUG

Methotrexate

DRUG

Contacts

BCC Enroll

CONTACT

7175310003 BCCEnroll@pennstatehealth.psu.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

Inclusion Criteria

Exclusion Criteria

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