History of Osteosarcoma metastatic to the lung(s). (First or second pulmonary recurrence(s) removed by surgery, and previous second-line systemic chemotherapy is allowed).
• Patients must be macroscopically disease free following pulmonary metastectomy of a single or multiple lesions. Complete Remission surgically (free of macroscopic disease) is required. Pleural disruption and/or microscopic positive margins are allowed
• Age ≥13 years.
• Patients must have recovered sufficiently from all acute adverse effects of prior therapies, excluding alopecia.
• Patients must have an ECOG performance status of 0-2. (Lansky score of 50-100 if < 16 years old).
• Patients must have recovered sufficiently from surgery and have adequate airflow and pulmonary reserve. This decision should be at the investigator’s discretion taking into consideration pre-surgery pulmonary function. (As a guideline: adequate airflow defined by a measured Forced Expiratory Volume (FEV1) not less than 50% of the predicted value and adequate pulmonary reserve as evidenced by a FEV1/FVC ratio of 65% or greater).
• Patients must have adequate renal function as defined by a serum creatinine of ≤ 1.5 mg/dl.
• Patients must have adequate liver function as defined by total bilirubin of ≤ 1.5 mg/dl and ALT or AST < 2.5 times the institution's upper normal limit.
• Patients must have adequate bone marrow function as defined by an absolute neutrophil count (ANC) of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3.
• Signed informed consent including, where applicable, the consent of the patient’s legal guardian.