PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma

Inclusion criteria:

Histologically confirmed stage IV melanoma

Stage M1a, M1b, or M1c
Mucosal, ocular, or unknown primary melanoma
Previously untreated OR received up to 3 prior systemic therapy regimens (excluding vaccine therapy) for metastatic disease
Plasma basic fibroblast growth factor level at least 15 pg/mL
Measurable or evaluable disease

Central nervous system (CNS) involvement allowed provided CNS directed therapy has been given and disease has been clinically stable for ≥ 3 months

Brain computed tomography (CT) scan or Magnetic resonance imaging (MRI) to confirm stable disease required ≤ 4 weeks prior to study entry
Age: 18 and over
ECOG Performance status of 0-2
Life expectancy at least 6 months
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 8 g/dL (transfusions allowed)
Bilirubin no greater than 2 times upper limit of normal (ULN)
Alanine Aminotransferase (ALT) no greater than 2 times ULN
Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min
At least 4 weeks since prior interferon in the adjuvant or metastatic setting
At least 4 weeks since prior chemotherapy in the adjuvant or metastatic setting
At least 4 weeks since prior endocrine therapy in the adjuvant or metastatic setting
At least 4 weeks since prior radiotherapy in the adjuvant or metastatic setting
At least 4 weeks since prior surgery in the adjuvant or metastatic setting
At least 4 weeks since other prior therapy in the adjuvant or metastatic setting
Negative pregnancy test
Fertile patients must use effective contraception

Exclusion criteria:

Myocardial infarction within the past 6 months
Other active malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
Other concurrent illness that would preclude study participation
History of severe depression
Pregnant or nursing