RecruitingPhase 1Phase 2NCT06892678
DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma
Sponsor
Montefiore Medical Center
Enrollment
15 participants
Start Date
Apr 7, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to determine the feasibility of administering DFMO to patients with relapsed Ewing sarcoma and osteosarcoma who have completed all planned therapy and have no evidence of disease.
Eligibility
Max Age: 39 Years
Inclusion Criteria10
- 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 Criteria3
- Pregnant or breastfeeding females
- Patients must not have an uncontrolled infection
- Patients must not have any significant intercurrent illness
Interventions
DRUGDFMO
DFMO dose will be calculated based on the BSA measured within 14 days prior to the beginning of each cycle. Tablets may be swallowed whole, chewed, or crushed and mixed with soft food or liquid.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06892678