Rituximab in Metastatic Melanoma

Phase 1

Terminated

• Conditions: Metastatic Melanoma
• Interventions: Drug: rituximab

• Registration Number: NCT01032122
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2009-09-19
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-24
• Last Update Posted: 2013-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rituximab	rituximab	-

Primary Outcome Measures

Name	Time	Method
disease-free interval	42 months

Secondary Outcome Measures

Name	Time	Method
overall survival	42 months

Trial Locations

Locations (1)

General Hospital Vienna, Dep. of Dermatology, Division of Immunology and Infectious Diseases; 🇦🇹 Vienna, Austria