|Inclusion Criteria:||1) Signed informed consent/assent by the patient or his/her legal guardian. Voluntary participation in the pharmacokinetic portion of the compassionate access protocol will be included in the informed consent but not required for compassionate use participation.|
2) Documented diagnosis of high grade osteosarcoma in patients with relapsed or recurrent disease, locally or metastatic, resectable or unresectable, who have failed prior recommended chemotherapy or have received an abbreviated chemotherapy regimen secondary to toxicity (e.g. hypophosphatemia from ifosfamide, cardiotoxicity from doxorubicin, renal dysfunction from methotrexate, ifosfamide, or cisplatin).
3) Ages 2 < / = 50 years.
4) Adequate hematopoietic function as demonstrated by: 1) Absolute Neutrophil Count (ANC) > 750/microL; Hemoglobin (Hb) > 8 g/dL; Platelets > 30,000/microL.
5) Adequate hepatic function as documented by 1) ALT < 2.5 x upper limit of normal (ULN) for age; 2) total bilirubin < / = 1.5 x ULN for age.
6) Adequate renal function as demonstrated by: 1) Creatinine clearance or radioisotope glomerular filtration rate > 70 mL/min/1.73 m^2; OR, 2) Serum creatinine < / = 2x ULN for age.
7) Absence of concurrent active acute infection (i.e., afebrile).
8) In females of child bearing potential (not menopausal for 12 months or no previous surgical sterilization), negative pregnancy test. All sexually active subjects will use an effective means of contraception. Such means include oral contraceptives, Lupron Depot, DepoProvera, and condom with diaphragm and spermicidal jelly).
9) Performance status: Lansky 50-100% (< / = 16 years of age); OR, ECOG 0-2 or Karnofsky 50-100% (>16 years of age).