Rituximab in Metastatic Melanoma

Efficacy and Safety of Rituximab, an Anti-CD20 (Cluster of Differentiation Antigen 20) Therapeutic Agent, in Metastatic Melanoma: a Pilot Study

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.

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