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

Launched by MONTEFIORE MEDICAL CENTER · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called DFMO for patients with relapsed Ewing sarcoma or osteosarcoma, two types of bone cancer. The goal is to see if DFMO can be safely used in patients who have finished all their planned treatments and currently show no signs of the disease. This is an early-stage study, and they haven’t started recruiting participants yet.

To be eligible for this trial, patients must be under 40 years of age and have a confirmed diagnosis of either relapsed osteosarcoma or Ewing sarcoma. They should also be in good overall health, meaning they can perform daily activities without much difficulty and have stable blood and organ functions. Importantly, women who are pregnant or breastfeeding, as well as those with ongoing infections or serious health problems, cannot participate. If chosen for the study, participants will receive DFMO and will be monitored closely to assess the treatment’s safety and effectiveness.

Gender

ALL

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
• * 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