Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB

Inclusion Criteria:

• Histologically proven cutaneous melanoma

• ≥ 18 years of age and < 75 years of age

• Have confirmed stage IIa (T3a), IIB, IIC, IIIA or IIIB (AJCC 2002) melanoma (lymphnode staging either per sentinel node biopsy or elective lymph node dissection)

• Have a Karnofsky performance status of ≥ 80%

• Negative pregnancy test

• Start of therapy within three months after surgery

• Informed consent

Exclusion Criteria:

• Pregnant or lactating women

• Unwillingness or inability to employ an effective barrier method of birth controlthroughout the study and for up to 3 months after end of treatment in female or malepatients

• Mucous membrane or ocular melanoma

• Any evidence of distant metastasis (CT-scan of brain, Chest X ray or CT, abdominalultrasound or CT and ultrasound of regional lymph nodes at screening)

• Patients who have received chemotherapy or vaccines for melanoma

• Patients with tumor progression under a previous adjuvant interferon therapy or withinthree months after termination of interferon therapy (patients previously receivingadjuvant interferon therapy in another tumor stage without disease progression may beincluded)

• History of any other malignancy within the last ten years (except basal cell carcinomaor squamous cell carcinoma of the skin and carcinoma in situ of the cervix)

• Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardialinfarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment,unstable angina), severe liver disease or severe renal disease.

• ALAT or ASAT > 2 x ULN

• Bilirubin > 2 x ULN

• Creatinine > 2 x ULN

• Patients who have a history of depression or other psychiatric diseases requiringhospitalisation

• Patients with seizure disorders requiring anticonvulsant therapy

• Any of the following abnormal baseline hematologic/laboratory values:

• Hb <10g/dl

• WBC <3.0 x 109 /l

• Platelets <100x109/l

• Neutrophils < 1.5 x 109/l

• History or presence of autoimmune disease (i.e. autoimmune hepatitis, thyroidauto-immune dysfunction, systemic lupus erythematodes)

• Unwilling or unable to comply with the requirements of the protocol for the durationof the study

• Known infection with HBV, HCV, HIV

• Evidence of allergy or hypersensitivity against IFN or pegylated interferon

• Thyroid disease poorly controlled on prescribed medications

• Systemic corticosteroid therapy for any reason (>1 month)