Rituximab in Metastatic Melanoma

April 24, 2013 updated by: Stephan N. Wagner, MD, Medical University of Vienna

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • General Hospital Vienna, Dep. of Dermatology, Division of Immunology and Infectious Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: rituximab
Drug: rituximab
induction phase: 375mg/m² qw, 4wks; followed by maintenance phase: 375mg/m², every 8 wks; duration: 2 years.
Other Names:
  • rituxan
  • mabthera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease-free interval
Time Frame: 42 months
42 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 42 months
42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Stephan Wagner, MD, Med Univ Vienna
  • Principal Investigator: Alice Pinc, MD, Medical Univ Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

September 19, 2009

First Submitted That Met QC Criteria

December 14, 2009

First Posted (ESTIMATE)

December 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 25, 2013

Last Update Submitted That Met QC Criteria

April 24, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIMM1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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