Rituximab in Metastatic Melanoma

Medical University of Vienna

Status and phase: Terminated; Phase 1

Conditions: Metastatic Melanoma

Treatments: Drug: rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT01032122

MIMM1

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

rituximab

Experimental group

Treatment:

Drug: rituximab