NCT06892678 DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma
| NCT ID | NCT06892678 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Montefiore Medical Center |
| Condition | Osteosarcoma Recurrent |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2030-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2025-04-07 with a primary completion date of 2030-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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 * 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 Criteria: * 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 * Patients with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of study agents or to significantly increase the severity of the toxicities experienced from study treatment are not eligible
Contact & Investigator
Alice Lee, MD
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT06892678 clinical trial?
This trial is open to participants of all sexes, up to 39 Years, studying Osteosarcoma Recurrent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06892678 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06892678 currently recruiting?
Yes, NCT06892678 is actively recruiting participants. Contact the research team at rzylber@montefiore.org for enrollment information.
Where is the NCT06892678 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT06892678 clinical trial?
NCT06892678 is sponsored by Montefiore Medical Center. The principal investigator is Alice Lee, MD at Montefiore Medical Center. The trial plans to enroll 15 participants.