Adjuvant PEG Intron in Ulcerated Melanoma

Exclusion Criteria

• •No mucosal melanoma nor ocular melanoma.
• •No evidence of nodal involvement confirmed by sentinel lymph node biopsy (SNB). Sentinel Node staging after the excision of the primary must be done between the date of final excision of the primary and the date of randomization.
• •No evidence of regional nor distant lymph node metastases nor satellites/in-transit metastases (even if they have been resected).
• •No evidence of distant metastasis on clinical examination, CT/MRI of full chest, abdomen and pelvis. Neck CT/MRI if head and neck primary.
• •No clinical evidence of brain metastasis.
• •No pregnant women
• •No breast feeding women
• •No experimental therapy within 30 days prior to randomization in this study.
• •No prior chemotherapy, immunotherapy/vaccine, hormonal or radiation therapy for melanoma.
• •No prior treatment with interferon-alfa for any reason.
• •No history of prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ.
• •No severe cardiovascular disease, i.e. arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) nor symptomatic ischemic heart disease.
• •No thyroid dysfunction not responsive to therapy.
• •No poorly controlled (HBA1C\>8%) diabetes mellitus or uncontrolled diabetes mellitus, i.e. elevated fasting serum glucose should be \< 110% ULN).
• •No active autoimmune disease.
• •No active and/or uncontrolled infection, including active hepatitis.
• •No history of seropositivity for HIV.
• •No history of neuropsychiatric disorder requiring hospitalization.
• •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.