Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083)

Inclusion Criteria:

* Male and female participants
* Age 18-70 years
* Malignant melanoma stage II or III (\>/= 1.5 mm tumor thickness, no distant metastases or Malignant melanoma with lymph node metastases or Lymph node metastases with unknown primary tumor
* An excision border of at least 2 cm around the primary tumor
* Therapy must start within 12 weeks after surgery of the tumor/of the lymph node metastases
* ECOG status 0-1 (= Karnofsky Index \>/= 80)
* Laboratory parameters

  * Hematocrit \>= 33%
  * Leukocytes \>= 3000/μl
  * Thrombocytes \>= 100000/μl
  * Alanine aminotransferase(ALT) \<= 2x normal values
  * Bilirubin \<= 2x normal values

Exclusion Criteria:

* Known allergy to one of the medications or any of its component parts
* Refusal on the part of participants capable of childbearing to use a reliable contraceptive
* Lactating mothers
* Presence of distant metastases
* Another primary tumor of different histological origin than corresponding to the indication (except when the relapse-free interval is \> 5 years, or the tumor is a cervical carcinoma in situ, a basal cell carcinoma or cutaneous squamous cell carcinoma)
* Participants on corticosteroid treatment or treatment with an immunomodulating substance
* Preexisting psychiatric illness, particularly serious depression
* Prior adjuvant radio-, chemo-, or immuno-therapy
* Treatment with an investigational drug within the prior 30 days
* Participant history that includes cardiac arrhythmia, cardiac insufficiency requiring treatment, or anthracycline administration
* Myocardial infarction within the prior year
* An unstable medical condition (apart from the indication) that in the judgment of the investigating physician excludes the participants from the study
* Psoriasis (a relative exclusion criterion, since interferon can aggravate psoriasis; decision to be based on risk/benefit analysis)