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

DISEASE CHARACTERISTICS:

• 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

• CNS involvement allowed provided CNS directed therapy has been given and disease has been clinically stable for ≥ 3 months

  • Brain CT scan or MRI to confirm stable disease required ≤ 4 weeks prior to study entry

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• 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)

Hepatic

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• ALT no greater than 2 times ULN

Renal

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance at least 60 mL/min

Cardiovascular

• No myocardial infarction within the past 6 months

Other

• No 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
• No other concurrent illness that would preclude study participation
• No history of severe depression
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 4 weeks since prior interferon in the adjuvant or metastatic setting

Chemotherapy

• At least 4 weeks since prior chemotherapy in the adjuvant or metastatic setting

Endocrine therapy

• At least 4 weeks since prior endocrine therapy in the adjuvant or metastatic setting

Radiotherapy

• At least 4 weeks since prior radiotherapy in the adjuvant or metastatic setting

Surgery

• At least 4 weeks since prior surgery in the adjuvant or metastatic setting

Other

• At least 4 weeks since other prior therapy in the adjuvant or metastatic setting