Rituximab in Metastatic Melanoma

This study has been terminated.
(the only reason is that recruitment was not sufficient to meet the planned patient numbers, because complete remissions are still infrequent.)
Sponsor:
Information provided by (Responsible Party):
Stephan N. Wagner, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01032122
First received: September 19, 2009
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Metastatic Melanoma
Drug: rituximab
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • disease-free interval [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: October 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032122

Locations
Austria
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
  More Information

No publications provided

Responsible Party: Stephan N. Wagner, MD, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01032122     History of Changes
Other Study ID Numbers: MIMM1
Study First Received: September 19, 2009
Last Updated: April 24, 2013
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by 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
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 22, 2014