Randomized, Multicenter, Open Label Study to Compare the Efficacy and Tolerability of Pegylated Interferon-alpha-2 (PEG-IFN) to 'Low-dose' Interferon-alpha-2a in Patients With Malignant Melanoma in Stages IIA (T3a) - IIIB (AJCC 2002)
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)