Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma

A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma

This trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles of therapy will be given to determine the anti-tumor response of the new chemotherapy. Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows continuing benefit.

Inclusion Criteria:

• Confirmed Metastatic Melanoma
• At least 18 years old
• No other active malignancy
• Hemoglobin at least 9
• Platelet Count at least 100,000 cells/mm3
• ANC at least 1500 cells/mm3
• AST & ALT less than 2.5X upper limit of normal
• Total bilirubin less than 1.5mg/dL
• Creatine less than 1.5 mg/dL
• Alkaline phosphatase less than 2.5X upper limit of normal
• Life expectancy of at least 12 weeks
• ECOG performance status of 0-1
• Patient must provide informed consent
• Patient must provide authorization to disclose

Exclusion Criteria:

• Evidence of active brain metastases
• The only evidence of metastasis is lytic or blastic bone metastases
• Pre-existing peripheral neuropathy of NCI Toxicity Criteria Scale of grade greater than 2
• Received radiotherapy in last 4wks, except if to a non-target lesion only
• Clinically significant concurrent illness
• Investigator's opinion that patient unlikely to complete study
• Cytotoxic chemotherapeutic agent treatment or investigational drug within previous 4wks
• History of allergy/hypersensitivity to study drug
• Serious Medical Risk Factors determine by the investigator