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Rituximab in Metastatic Melanoma

Sponsor
Medical University of Vienna (Other)
Overall Status
Terminated
CT.gov ID
NCT01032122
Collaborator
(none)
9
Enrollment
1
Location
1
Arm
43
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Rituximab, an Anti-CD20 (Cluster of Differentiation Antigen 20) Therapeutic Agent, in Metastatic Melanoma: a Pilot Study
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
May 1, 2011

Arms and Interventions

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:
  • mabthera
  • rituxan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. disease-free interval [42 months]

    Secondary Outcome Measures

    1. overall survival [42 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 General Hospital Vienna, Dep. of Dermatology, Division of Immunology and Infectious Diseases Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephan N. Wagner, MD, MD, Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT01032122
    Other Study ID Numbers:
    • MIMM1
    First Posted:
    Dec 15, 2009
    Last Update Posted:
    Apr 25, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by Stephan N. Wagner, MD, MD, Medical University of Vienna
    melanoma
    rituximab
    metastatic
    stage IIIc/IV
    stem cell
    overall survival
    disease free interval
    anti-CD20 therapy
    Additional relevant MeSH terms:
    Melanoma
    Rituximab

    Study Results

    No Results Posted as of Apr 25, 2013