Rituximab in Metastatic Melanoma

Phase 1TerminatedNCT01032122

Medical University of Vienna9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Melanoma

Interventions

rituximabDRUG

induction phase: 375mg/m² qw, 4wks; followed by maintenance phase: 375mg/m², every 8 wks; duration: 2 years.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

General Hospital Vienna, Dep. of Dermatology, Division of Immunology and Infectious Diseases

Vienna, Austria

Outcomes

Primary Outcomes

disease-free interval

Time frame: 42 months

Secondary Outcomes

overall survival

Time frame: 42 months

Data from ClinicalTrials.gov

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