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

Dermatologic Cooperative Oncology Group

Status and phase

Unknown

Phase 3

Conditions

Interferon Alpha

Stage III Malignant Melanoma

Therapy

Adjuvant

Treatments

Drug: Interferon-alpha-2b

Study type

Interventional

Funder types

Other

Identifiers

NCT00226408

MM-ADJ-5

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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