Interferon Beta in Treating Patients With Metastatic Cutaneous Melanoma or Ocular Melanoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed metastatic melanoma
• •* Cutaneous or ocular disease
• •Measurable disease
• •No active unstable CNS metastases by neurologic exam AND CT scan or MRI
• •* Irradiated and/or resected CNS lesions allowed if there is no evidence of disease by head MRI or CT scan for \> 6 months after surgery and/or radiotherapy
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •ECOG 0-1 (0-2 for patients with cutaneous metastases)
• •Life expectancy
• •At least 3 months
• •Hematopoietic
• •Absolute neutrophil count ≥ 1,200/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 9.5 g/dL
• •Hepatic
• •Bilirubin ≤ 1.5 mg/dL
• •AST ≤ 3.0 times normal
• •Alkaline phosphatase ≤ 2.5 times normal (10 times normal if due to bone metastases)
• •Hepatitis B surface antigen negative
• •Renal
• •Creatinine ≤ 1.5 mg/dL
• •Cardiovascular
• •No serious cardiac arrhythmia requiring treatment
• •No congestive heart failure
• •No angina pectoris
• •No New York Heart Association class II-IV heart disease
• •No other severe cardiovascular disease
• •Other
• •HIV negative
• •No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the uterine cervix
• •No history of seizure disorder
• •No severe psychiatric disorder
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •More than 12 months since prior adjuvant interferon alfa-2 (IFNα-2) therapy
• •More than 30 days since prior IFNα-2 therapy for metastatic disease (6 months for patients with cutaneous metastases)
• •No more than 1 prior systemic regimen (chemotherapy or biologic) for metastatic disease (3 regimens for patients with cutaneous metastases)
• •Chemotherapy
• •See Biologic therapy
• •No concurrent chemotherapy
• •Endocrine therapy
• •See Disease Characteristics
• •Concurrent replacement therapy with physiologic doses of corticosteroids allowed
• •* No concurrent dexamethasone or other steroidal antiemetics or anti-inflammatories
• •No other concurrent hormonal agents except steroids administered for preexisting adrenal failure or hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
• •Radiotherapy
• •See Disease Characteristics
• •More than 28 days since prior radiotherapy and recovered
• •No concurrent palliative radiotherapy
• •Surgery
• •See Disease Characteristics
• •No prior organ allograft
• •More than 28 days since prior major surgery requiring general anesthesia
• •Other
• •More than 28 days since prior antibiotics for local or systemic infection
• •No concurrent aspirin
• •No concurrent barbiturates
• •No other concurrent investigational agents