Metastatic Melanoma
Conditions
Keywords
melanoma, rituximab, metastatic, stage IIIc/IV, stem cell, overall survival, disease free interval, anti-CD20 therapy
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.
Interventions
DRUGrituximab
induction phase: 375mg/m² qw, 4wks; followed by maintenance phase: 375mg/m², every 8 wks; duration: 2 years.
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free interval | 42 months |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | 42 months |
Countries
Austria
Outcome results
None listed