Bevacizumab, Dacarbazine and Interferon-Alfa to Treat Metastatic Melanoma

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether combination therapy with bevacizumab (Avastin), dacarbazine and interferon-alfa-2a (Roferon-A) is effective in patients with locally advancing or metastatic melanoma.

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

Details

• Lead Sponsor: University of Turku
• Treatments: Bevacizumab; Dacarbazine; Interferon alpha-2; Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

• histologically confirmed malignant melanoma either locally progressing inoperable or metastatic

• measurable/evaluable disease in accordance with RECIST criteria

• WHO performance status 0-2

• normal organ function

• signed written informed consent

Exclusion Criteria:

• unevaluable disease

• major surgery within 28 days prior to day 0

• uncompleted radiotherapy

• CNS metastases

• serious non-healing wound or ulcer

• bleeding diathesis or coagulopathy

• uncontrolled hypertension

• clinically significant cardiovascular disease

• depression or psychosis, which needs medication

• ongoing treatment with aspirin (>325 mg/day)

• pregnancy

• any other serious or uncontrolled illness

• previous chemotherapy for metastatic melanoma