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 (lymph node 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 control throughout the study and for up to 3 months after end of treatment in female or male patients
• Mucous membrane or ocular melanoma
• Any evidence of distant metastasis (CT-scan of brain, Chest X ray or CT, abdominal ultrasound 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 within three months after termination of interferon therapy (patients previously receiving adjuvant interferon therapy in another tumor stage without disease progression may be included)
• History of any other malignancy within the last ten years (except basal cell carcinoma or 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, myocardial infarction 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 requiring hospitalisation
• 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, thyroid auto-immune dysfunction, systemic lupus erythematodes)
• Unwilling or unable to comply with the requirements of the protocol for the duration of 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)