Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma

Inclusion Criteria

• •At least 18 years of age
• •Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
• •Pathologically confirmed diagnosis of soft tissue sarcoma
• •Locally advanced unresectable or metastatic disease with no standard curative therapy available that has progressed since the most recent therapy
• •Measurable disease by RECIST criteria with at least one target lesion
• •1 or 2 prior chemotherapy/systemic therapy regimens for advanced disease
• •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
• •A minimum of 3 weeks between prior chemotherapy, radiation therapy, immunotherapy, or other anti-tumor therapy and study entry
• •Recovered from reversible toxicities of prior therapy
• •Hemoglobin ≥ 9.0 g/dL, neutrophils ≥ 1,500/µL, platelets ≥ 100,000/µL
• •Total bilirubin ≤ 1.5-fold ULN, AST/ALT ≤ 2.5-fold ULN (≤ 5-fold if liver metastases)
• •Normal creatinine clearance (≥85 mL/min for men and ≥75 mL/min for women; calculated by Cockcroft-Gault formula
• •All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose