Trial | NCT00226408  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    600
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.
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 Started
Nov 30
2003
Study Completion
Sep 30
2005
Last Update
Jun 21
2006
Estimate

Drug Interferon-alpha-2b

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
No Results Posted