Rituximab in Metastatic Melanoma

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether rituximab as an adjuvant therapy in clinical stage IIIc / IV (no evidence of disease, AJCC (American Joint Committee on Cancer) 2002) melanoma patients is safe and prolongs overall survival and disease-free interval.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Histologically verified non-ocular melanoma stage IIIc/IV, no evidence of disease

Exclusion Criteria:

• ECOG (Eastern Cooperative Oncology Group) performance status > 2

• Ocular melanoma

• Immunodeficiency syndromes or hypogammaglobulinaemia

• Active autoimmune diseases

• Treatment with immunosuppressive agents other than steroids

• Depressed bone marrow function (Leukopenia <3000, platelet count <100.000)

• Cardiac insufficiency NYHA (New York Heart Association) IV

• active Hepatitis B,C, or HIV infection

• Pregnancy or lactation

• Interstitial pulmonary disease

• Former treatment with anti-CD20 antibody