Randomized, Multicenter Study for Adjuvant Treatment of Stage III Malignant Melanoma: Intermittent, High-Dose Intravenous Interferon Alpha-2b Versus Standard High-Dose Interferon Alpha-2b Therapy
Arm A: Interferon-alpha-2b 20 MIU/m2 for 4 weeks. 5 days a week i.v followed by 48 weeks of
treatment with 3 x 10 MIU/m2 s.c Arm B: Interferon-alpha-2b 20 MIU/m2 for 4 weeks. 5 days a
week i.v repeated 3 times with 12 treatment-free-weeks between the cycles
Secondary endpoints: Improved overall survival rate, Assess side effects of therapy in both
treatment arms, Assess time spent on sick leave, Assess number of treatment-related days in
hospital, Assess overall performance status, Assess blood MX protein levels
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
distant metastasis free survival/(DMFI )
Peter Mohr, MD
Principal Investigator
Elbeklinikum, Buxtehude, Germany
Germany: Federal Institute for Drugs and Medical Devices
MM-ADJ-5
NCT00226408
November 2003
September 2005
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