DFMO Maintenance for the Treatment of Patients with Relapsed Ewing Sarcoma or Osteosarcoma

Inclusion Criteria

• Patients < 40 years of age at the time of enrollment are eligible for this study
• Diagnosis of relapsed osteosarcoma or relapsed Ewing sarcoma. Patient must have completed all planned therapy for their relapse 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. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age
• 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 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
• Peripheral absolute neutrophil count (ANC) ≥ 750/μL (performed within 14 calendar days prior to enrollment)
• Platelet count ≥ 75,000/μL (transfusion independent) (performed within 14 calendar days prior to enrollment)
• A serum creatinine based on age/gender as follows (performed within 14 calendar days prior to enrollment): * Age: 1 to < 2 years; Maximum serum creatinine (mg/dL): 0.6 (male) 0.6 (female) * Age: 2 to < 6 years; Maximum serum creatinine (mg/dL): 0.8 (male) 0.8 (female) * Age: 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 (male) 1 (female) * Age: 10 to < 13 years; Maximum serum creatinine (mg/dL): 1.2 (male) 1.2 (female) * Age: 13 to < 16 years; Maximum serum creatinine (mg/dL): 1.5 (male) 1.4 (female) * Age: ≥ 16 years; Maximum serum creatinine (mg/dL): 1.7 (male) 1.4 (female)
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (performed within 14 calendar days prior to enrollment)
• Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) ≤ 5.0 x ULN for age (performed within 14 calendar days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria

• Patients must not have an uncontrolled infection
• 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 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