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Trial · NCT07321912

Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

NCT07321912, Phase 2, Recruiting, Milton S. Hershey Medical Center

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma. Trials, record NCT07321912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07321912

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma
NCT number
NCT07321912
Status
Recruiting
Phases
Phase 2
Enrollment
406 participants, estimated
Lead sponsor
Milton S. Hershey Medical Center
Conditions
Osteosarcoma, Ewing Sarcoma
Interventions
Eflornithine, Topotecan, Cyclophosphamide, Vincristine, Doxorubicin, Ifosfamide, Etoposide, Cisplatin, Methotrexate
First posted
2026-01-07
Last updated
2026-10-06

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Cohort 1 participants with relapse free survival (RFS) during study2 years plus 5 years follow up
Cohort 1: To determine if relapse-free survival (RFS) in participants with relapsed or refractory Ewing sarcoma treated with multiagent chemotherapy is improved with the addition of DFMO as compared to historical outcomes of participants treated with the same multiagent chemotherapy without DFMO.
PrimaryNumber of Cohort 2 participants with event-free survival (EFS) during study2 years plus 5 years follow up
Cohort 2: To determine if event-free survival (EFS) in participants with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy is improved with the addition of DFMO as compared to historical outcomes of participants treated with the same multiagent chemotherapy without DFMO.
PrimaryCohort 3: Number of Cohort 3 participants at 12 months with disease control1 year plus 5 years follow upTo determine the 12-month disease control rate (DCR) in participants with completely resected recurrent osteosarcoma treated with DFMO as compared to historical controls.
PrimaryCohort 4A: Number of Cohort 4A participants with event-free survival (EFS) during study2 years plus 5 years follow up
Examine whether the addition of DFMO to post-operative chemotherapy with cisplatin, doxorubicin, and methotrexate (MAP) improves the event-free survival (EFS) for participants with osteosarcoma having localized disease with a poor histological response to 10 weeks of pre-operative chemotherapy.
PrimaryCohort 4B: Number of Cohort 4B participants with event-free survival (EFS) during study2 years plus 5 years follow up
Examine whether the addition of DFMO to post-operative chemotherapy with cisplatin, doxorubicin, and methotrexate (MAP) improves the event-free survival (EFS) for participants with osteosarcoma with metastatic disease at diagnosis (Cohort 4B).
SecondaryLength of time that participants experience Overall Survival (OS)10 YearsTo compare overall survival in DFMO-treated participants versus historical controls.
SecondaryNumber of Participants with Adverse Events as a Measure of Safety and Tolerability2 yearsTo characterize safety and tolerability of DFMO plus multiagent chemotherapy.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07321912

GET https://conductscience.org/api/trials/v1/NCT07321912/registered