Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor

Inclusion Criteria

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