Standard High-Dose Alpha Interferon Versus Intermittent High-Dose Alpha Interferon ODM derived from

  1. 2/13/12 2/13/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
  3. 6/6/15 6/6/15 - Martin Dugas
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June 6, 2015

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Melanoma Eligibility Interferon Alpha NCT00226408

Eligibility Melanoma NCT00226408

  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT00226408
Inclusion Criteria
18 Years to 70 Years
Histological documented cutaneous malignant melanoma Stage IIIa, IIIb, IIIc (AJCC 2002)
R0 resection dating back no longer than 56 days
Performance status (ECOG 0-1)
Bone marrow funktion: White cell count > 3000 cells/ul, platelets > 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
Medical concepts

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