DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma
Montefiore Medical Center
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.
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 as DFMO or eflornithine, is a synthetic analog of the amino acid ornithine. DFMO has been studied in a number of different cancers as either a therapeutic or a chemopreventative agent and is now FDA approved to reduce the risk of relapse in patients with newly diagnosed high-risk neuroblastoma. As DFMO has now been given to over 100 children with metastatic cancer, dosing and safety in this popul…
Eligibility
- Age range
- Up to 39 years
- Sex
- All
- Healthy volunteers
- No
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…
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.
Location
- Montefiore Medical CenterThe Bronx, New York