Use of 852A in Metastatic Cutaneous Melanoma.

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

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