NCT00226408

Standard High-Dose Alpha Interferon Versus Intermittent High-Dose Alpha Interferon

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (planned)
• Sponsor: Dermatologic Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study protocol is being conducted to compare intermittent high-dose i.v. administation of interferon alpha-2b with the standard high-dose treatment by Kirkwood with distant metastasis free survival (DMFI) as a primary endpoint.

Detailed description

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

Conditions

• Adjuvant
• Stage III Malignant Melanoma
• Interferon Alpha
• Therapy

Interventions

Type	Name	Description
DRUG	Interferon-alpha-2b

Timeline

• Start date: 2003-11-01
• Completion: 2005-09-01
• First posted: 2005-09-27
• Last updated: 2006-06-21

Locations

13 sites across 1 country: Germany