Actively Recruiting
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
260 weeks
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
The purpose of this study is to determine the feasibility of administering DL-alpha-difluoromethylornithine (DFMO) to patients with relapsed Ewing sarcoma and osteosarcoma who have completed all planned therapy and have no evidence of disease.
CONDITIONS
Official Title
DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients under 40 years of age at enrollment
- Diagnosis of relapsed osteosarcoma or relapsed Ewing sarcoma who have completed all planned therapy for their relapse and have no evidence of disease
- Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale
- At least 14 days since completion of myelosuppressive chemotherapy
- At least 21 days since last monoclonal antibody infusion, with recovery from related toxicity to less than Grade 2
- At least 7 days since last dose of biologic therapy (non-myelosuppressive anti-cancer agents)
- At least 14 days since local external beam radiation therapy, 90 days since total body irradiation or craniospinal radiation, or 42 days since other substantial bone marrow radiation
- Adequate bone marrow function: absolute neutrophil count ≥ 750/microliter and platelet count ≥ 75,000/microliter (transfusion independent)
- Adequate renal function based on serum creatinine adjusted for age and gender
- Adequate liver function: total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age and ALT ≤ 5.0 times ULN (ULN is 45 U/L)
You will not qualify if you...
- Pregnant or breastfeeding females
- Men and women of childbearing potential and their partners who do not agree to use adequate contraception during the study
- Females of childbearing potential without a negative pregnancy test
- Patients with uncontrolled infection
- Patients with significant ongoing medical illnesses unrelated to cancer or its treatment that could interfere with study agents or increase treatment toxicity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
R
Rebecca Zylber, MSN
CONTACT
L
Lara Fabish, MSN
CONTACT
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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