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DFMO Maintenance for Relapsed Ewing Sarcoma or Osteosarcoma

This study is looking at how practical it is to give a drug called DFMO (DL-alpha-difluoromethylornithine) to patients with relapsed (returned) Ewing sarcoma or osteosarcoma. You might be able to join if you are under 40, have had relapsed Ewing sarcoma or osteosarcoma, have finished all your previous treatments, and currently have no signs of cancer. DFMO is already approved for other cancers to help prevent them from coming back. The main goal of this study is to see if it's feasible to give DFMO to patients like you to try and prevent the cancer from returning. The study plans to enroll 15 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment (DFMO). It aims to enroll 15 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, feasibility of administering DFMO, is measured for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06892678

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

Recruiting
PHASE1Up to 39InterventionalTreatment
Montefiore Medical Center
~15 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:DFMO

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of Administering DFMO
Measured over Up to 2 years

Conditions

Osteosarcoma Recurrent
Ewing's Tumor Recurrent

Explore related trials

Ewing SarcomaOsteosarcoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Alice Lee, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Rebecca Zylber, MSN
[email protected]
718-741-2356
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients \< 40 years of age at the time of enrollment
Diagnosis of relapsed osteosarcoma or relapsed Ewing sarcoma who have completed all planned therapy for their relapse, as described in the protocol, and have no evidence of disease
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2
Myelosuppressive chemotherapy: At least 14 days must have elapsed since completion of myelosuppressive therapy
Monoclonal antibodies: At least 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to Grade \< 2
Biologic therapy (defined as anti-cancer agents not known to be myelosuppressive): At least 7 days after the last dose of agent
Radiation therapy: At least 14 days must have elapsed after local External Beam Radiation Therapy (XRT), at least 90 days after Total Body Irradiation (TBI), craniospinal XRT or if radiation to greater than 50% of the pelvis, and at least 42 days if other substantial bone marrow radiation
Adequate bone marrow function defined as:
Peripheral absolute neutrophil count (ANC) greater or equal to 750/microliter
Platelet count greater or equal to 75,000/microliter (transfusion independent)
Adequate renal function defined by serum creatinine based on age and gender (see protocol)
Adequate liver function defined as:
Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) for age AND
SGPT (ALT) ≤ 5.0 x ULN for age. For this study the ULN is 45 U/L

Exclusion

Pregnant or breastfeeding females. Men and women of childbearing potential and their partners must agree to use adequate contraception while enrolled on this study. Based on the teratogenic potential of the agent, pregnant women will be excluded from this study. Because of potential risks to breastfed infants due to drug metabolites that could be excreted in breast milk, female patients who are lactating must agree to stop breastfeeding or will otherwise be excluded from this study. Females of childbearing potential must have a negative pregnancy test to be eligible for this study
Patients must not have an uncontrolled infection

What this trial measures

  • Feasibility of Administering DFMOUp to 2 years

    Feasibility will be defined as the ability to successfully administer DFMO to at least 80% of subjects who initiate therapy until either disease recurrence or completion of the maximally allowed duration of therapy. Results will be summarized using basic descriptive statistics.