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

Phase 3

• Conditions: Adjuvant; Stage III Malignant Melanoma; Interferon Alpha; Therapy

• Registration Number: NCT00226408
• Lead Sponsor: Dermatologic Cooperative Oncology Group

Brief 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

Study Timeline

• Study Start: 2003-11
• Status Verified: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-09-25
• Study First Submitted QC: 2005-09-25
• Study First Posted: 2005-09-27
• Last Update Submitted: 2006-06-20
• Last Update Posted: 2006-06-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Histological documentet cutaneous malognant melanoma
• Stage IIIa, IIIb, IIIc (AJCC 2002)
• R0 resection dating back no longer than 56 days
• Performance status (ECOG o-1)
• Bone marrow funktion: White cell count > 3000 cells/ul, platletts > 100000 cells/ul, hemoglobin > 10 g/dl
• Liver and kidney funktion: Serum creatinin < 1.5 times upper limit of normal, AST and ALT < 2.5 times upper limit of normal, Serum bilirubin < 2 times upper limit of normal
• Written inform consent

Exclusion Criteria

• Confirmed distant metastasis
• Choroid or mucosal melanoma
• Pregnant or lactating women and women of childbearing potential not using a reliable form of contraception
• Active autoimmun disease
• patients with history of neuropsychiatric disease requiring hospitalization
• Severe medical condition such us:
• Florid hepatitis
• Severe acute infection
• Myocardial infarction within the past year,symptomatic angina pectoris
• Grade III to IV congestive heart failure
• serious pulmonary disease
• HIV-positive patients with an AIDS - defining condition
• treatment in another clinical drug trial within the last 30 days
• A history of hypersensitivity to interferon alfa
• History of maignant disease during the past 5 years (except for curatively treated skin carcinoma or in situ carcinoma)
• Prior high dose interferon alfa therapy.Prior adjuvant low dose or intermediate-dose interferon alfa therapy is allowed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
distant metastasis free survival/(DMFI )

Secondary Outcome Measures

Name	Time	Method
overall survival
time to progression
toxicity

Trial Locations

Locations (13)

Universitätshautklinik Heidelberg; 🇩🇪 Heidelberg, Germany

Christian- Albrechts- Universität ,Hautklinik; 🇩🇪 Kiel, Germany

Universitätshautklinik Ulm; 🇩🇪 Ulm, Germany

Universitätsklinikum des Saarlandes, Hautklinik; 🇩🇪 Homburg/ Saar, Germany

Praxis; 🇩🇪 Hannover, Germany

Universitätshautklinik Köln; 🇩🇪 Köln, Germany

Universitätshautklinik Mainz; 🇩🇪 Mainz, Germany

universitätsklinikum Münster; 🇩🇪 Münster, Germany

Universitätshautklinik Essen; 🇩🇪 Essen, Germany

Universitätshautklinik ,St.Josef- Hospital; 🇩🇪 Bochum, Germany

Universitätsklinik Eppendorf; 🇩🇪 Hamburg, Germany

Städtische Kliniken Oldenburg; 🇩🇪 Oldenburg, Germany

Elbekliniken Buxtehude; 🇩🇪 Buxtehude, Germany