Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.
- 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
- Adequate contraception for females of childbearing potential
- 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