Actively Recruiting

Phase 1
Phase 2
Age: 0 - 39Years
All Genders
ID06892678

DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma

Led by Montefiore Medical Center · Updated on 2026-05-14

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Montefiore Medical Center

Lead Sponsor

J

Johns Hopkins University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to determine if it is feasible to give DL-alpha-difluoromethylornithine (DFMO) to patients with relapsed Ewing sarcoma or osteosarcoma who have finished all planned treatments and show no signs of disease. These cancers often relapse, leading to poor outcomes, and DFMO, a synthetic analog of ornithine, has been studied in various cancers and approved by the FDA to reduce relapse risk in certain high-risk cancers. The study explores whether DFMO can help prevent recurrence in these patients. Participants will receive DFMO orally twice daily in 28-day cycles. The dose depends on the patient's body surface area, with tablets provided in specific amounts ranging from one to four tablets per dose. The tablets may be swallowed whole, chewed, or mixed with food or liquid. This treatment will continue for up to two years to assess feasibility and outcomes. During the study, patients will be monitored for how well they tolerate DFMO and for any signs of cancer recurrence. Researchers will assess feasibility of administering DFMO and track event-free survival for up to two years. Patients need to meet specific health and recovery criteria before starting and will have regular assessments to monitor blood counts, kidney and liver function, and overall health throughout the study period.

CONDITIONS

Brief Title

DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma

Who Can Participate

Age: 0 - 39Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients younger than 40 years old at enrollment
  • Diagnosis of relapsed osteosarcoma or relapsed Ewing sarcoma with no evidence of disease after completing all planned therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • At least 14 days since completing myelosuppressive chemotherapy
  • At least 21 days since last monoclonal antibody infusion with recovery to Grade less than 2 toxicity
  • At least 7 days since last biologic therapy not known to be myelosuppressive
  • At least 14 days since local external beam radiation therapy, at least 90 days since total body irradiation or craniospinal radiation, and at least 42 days since other substantial bone marrow radiation
  • Adequate bone marrow function with neutrophil count ≥ 750/microliter and platelet count ≥ 75,000/microliter
  • Adequate kidney function based on serum creatinine by age and gender
  • Adequate liver function with total bilirubin ≤ 1.5 times upper limit normal and SGPT (ALT) ≤ 5 times upper limit normal
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding females
  • Men and women of childbearing potential and their partners must agree to use effective contraception during the study
  • Patients with uncontrolled infection
  • Patients with significant ongoing serious medical problems unrelated to cancer that interfere with study treatment or increase toxicity risk

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 years

Participants take DFMO orally every 12 hours in 28-day cycles with dosage based on body surface area to help prevent disease recurrence.

Visits every 28 days for treatment cycles

Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

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Research Team

R

Rebecca Zylber, MSN

L

Lara Fabish, MSN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

Outcome of patients with relapsed or progressive Ewing sarcoma enrolled on cooperative group phase 2 clinical trials: A report from the Children's Oncology Group.

Anderson B Collier, Mark D Krailo, Ha M Dang...

https://pubmed.ncbi.nlm.nih.gov/34496122

Outcome of Patients With Recurrent Osteosarcoma Enrolled in Seven Phase II Trials Through Children's Cancer Group, Pediatric Oncology Group, and Children's Oncology Group: Learning From the Past to Move Forward.

Joanne P Lagmay, Mark D Krailo, Ha Dang...

https://pubmed.ncbi.nlm.nih.gov/27400942