Efficacy and Safety of Rituximab, an Anti-CD20 (Cluster of Differentiation Antigen 20) Therapeutic Agent, in Metastatic Melanoma: a Pilot Study
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Metastatic Melanoma
Both
Metastatic Melanoma
Trial Information
Efficacy and Safety of Rituximab, an Anti-CD20 (Cluster of Differentiation Antigen 20) Therapeutic Agent, in Metastatic Melanoma: a Pilot Study
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
disease-free interval
Outcome Time Frame:
42 months
Safety Issue:
No
Principal Investigator
Stephan Wagner, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Med Univ Vienna
Authority:
Austria: Agency for Health and Food Safety
Study ID:
MIMM1
NCT ID:
NCT01032122
Start Date:
October 2007
Completion Date:
May 2011
Related Keywords:
- Metastatic Melanoma
- melanoma
- rituximab
- metastatic
- stage IIIc/IV
- stem cell
- overall survival
- disease free interval
- anti-CD20 therapy
- Melanoma
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