Using DFMO to prevent relapse in patients with Ewing sarcoma or osteosarcoma
DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma
PHASE1; PHASE2 · Montefiore Medical Center · NCT06892678
This study is testing if a drug called DFMO can help prevent relapse in young patients who have finished treatment for Ewing sarcoma or osteosarcoma.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | N/A to 39 Years |
| Sex | All |
| Sponsor | Montefiore Medical Center (other) |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06892678 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of administering DFMO, a synthetic analog of the amino acid ornithine, to patients under 40 years old who have relapsed Ewing sarcoma or osteosarcoma and have completed all planned therapy without evidence of disease. DFMO has been previously used in various cancers and is FDA approved for reducing relapse risk in high-risk neuroblastoma. The study will focus on determining the safety and potential effectiveness of DFMO in preventing disease recurrence in this high-risk population. Approximately 30-35% of patients with these conditions experience relapse, highlighting the need for new preventative strategies.
Who should consider this trial
Good fit: Ideal candidates are patients under 40 years old with a diagnosis of relapsed Ewing sarcoma or osteosarcoma who have completed all planned therapy and have no evidence of disease.
Not a fit: Patients who are pregnant, breastfeeding, or have uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of relapse in young patients with Ewing sarcoma and osteosarcoma.
How similar studies have performed: Previous studies have shown success with DFMO in other cancer types, but its application in relapsed Ewing sarcoma and osteosarcoma is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Adequate bone marrow function defined as: * Peripheral absolute neutrophil count (ANC) greater or equal to 750/microliters * Platelet count greater or equal to 75,000/microliters (transfusion independent) * Adequate renal function defined by serum creatinine based on age and gender * 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 Criteria: * Pregnant or breastfeeding females * Patients must not have an uncontrolled infection * Patients must not have any significant intercurrent illness
Where this trial is running
The Bronx, New York
- Montefiore Medical Center — The Bronx, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Alice Lee, MD — Montefiore Medical Center
- Study coordinator: Rebecca Zylber, MSN
- Email: rzylber@montefiore.org
- Phone: 718-741-2356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteosarcoma Recurrent, Ewing's Tumor Recurrent