Use of 852A in Metastatic Cutaneous Melanoma.

Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.

Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week for 12 weeks in subjects with inoperable metastatic cutaneous melanoma.

Inclusion Criteria:

• Advanced melanoma not responding to 1st line chemotherapy
• Histological evidence of melanoma
• Measurable disease according to RECIST criteria
• ECOG performance status less than or equal to 2
• Life expectancy 6 months or more
• Normal organ and bone marrow function as defined by hematological and serum chemistry limits
• Adequate contraception for females of childbearing potential

Exclusion Criteria:

• Stage IV disease which has previously progressed during interferon treatment.
• Restriction of some therapies/medications for a certain timeframe prior to enrollment and during the study including: investigational drugs, high dose corticosteroids, immunotherapy, immunosuppressive medications, radiotherapy and drugs known to prolong QT interval and/or induce Torsades De Pointes
• History of uncontrolled seizure disorders
• Uncontrolled coagulation disorders.
• History or evidence of myocardial ischemia, congestive heart failure or arrythmias requiring treatment in the past 6 months
• History of uncontrolled intercurrent or chronic illness
• Concurrent malignancies.
• Brain metastases.
• HIV positive.
• Prolonged QTc interval
• Uncontrolled intercurrent or chronic illnesses.
• Pregnant or lactating women