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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Adjuvant, Stage III Malignant Melanoma, Interferon Alpha, Therapy

Intervention / Treatment
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* Drug: Interferon-alpha-2b


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interferon-alpha-2b|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distant metastasis free survival/(DMFI ) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  |  | 
| time to progression |  |  | 
| toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melanoma,adjuvant therapy,stageIII Interferon, high dose