metastatic melanoma patients, clinical stage IIIc/IV ( AJCC2002), disease free
Conditions
Interventions
Trade Name: Mabthera
Product Name: MabThera
Product Code: EU/1/98/067/002
Pharmaceutical Form: Intravenous infusion
Sponsors
Medizinische Universität Wien, Univ.Klinik für Dermatologie, Abteilung für Immundermatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: male/female melanoma patients >18 years stage IIIc/IV disease free negative pregnancy test ECOG status=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: other tumors ( except basal cell Ca and squamous cell Ca) mucosal and uveal melanomas chronic infectious diseases autoimmune diseases or/ and immunosupressive therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: time to progression overall survival;Secondary Objective: quality of life;Primary end point(s): 15 Patients 2 years period tumor progression | — |
Countries
Austria
Outcome results
None listed