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

• Status: Unknown status
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dermatologic Cooperative Oncology Group
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons

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