| Inclusion Criteria: | 1) Male or female subjects 18 years of age or older.
2) Unresectable advanced or metastatic histologically proven non L-type STS. Eligibility will include desmoplastic small round cell tumor, Ewing's sarcoma, and osteosarcoma. - The site must provide documentation to the sponsor of the subject's non L-type sarcoma diagnosis prior to their enrollment.
3) Clinically significant uncontrolled cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias.
4) Recovery from toxic effects of prior therapies to Grade 1 or better according to National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE, Version 3).
5) Hematologic test results: Hemoglobin greater than or equal to 8 g/dL, absolute neutrophil count (ANC) greater than or equal to 1,500/microliter, platelet count greater than or equal to 100,000/microliter.
6) Clinical chemistry test results: Serum creatinine less than or equal to 1.5 times the upper limit of normal (ULN), or if serum creatinine is greater than 1.5 times the ULN, then 24 hour creatinine clearance of greater than 50 cc/min, creatine phosphokinase (CPK) less than or equal to 2.5 times the ULN.
7) Hepatic function test results: Total bilirubin less than or equal to ULN, if increased then measure indirectly to rule out Gilbert's syndrome. If direct bilirubin is within normal limits, subject may be considered eligible. ALP less than or equal to 2.5 x ULN; or if greater than 2.5 x ULN, ALP liver fraction or 5" nucleotidase must be less than or equal to ULN. AST and ALT must be less than or equal to 2.5 x ULN.
8) Female subjects must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g.; prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) before entry and throughout the study, and have a negative urine or serum pregnancy test result at screening. For male partners acceptable methods of birth control include sterilization, barrier contraception, and abstinence.
9) Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. |