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ClinicalTrials.gov ID

NCT00226408

Lead Sponsor

Dermatologic Cooperative Oncology GroupOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

600

Last Update Posted

Jun 21, 2006Estimated

Start Date

Nov 2003

Completion Date

Sep 2005

Official Title

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

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

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

• Interferon-alpha-2b

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Dermatologic Cooperative Oncology GroupOTHER

0049/511 ext. 3069998