Status:
RECRUITING
DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Osteosarcoma Recurrent
Ewing's Tumor Recurrent
Eligibility:
All Genders
Up to 39 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
Approximately 30-35% of patients diagnosed with osteosarcoma or Ewing sarcoma will develop relapsed/refractory disease and carry a very poor prognosis. DL-alpha-difluoromethylornithine, commonly known...
Eligibility Criteria
Inclusion
- 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
- Pregnant or breastfeeding females
- Patients must not have an uncontrolled infection
- Patients must not have any significant intercurrent illness
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2030
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06892678
Start Date
April 7 2025
End Date
April 1 2030
Last Update
May 11 2025
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467