Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma

Date de début de l'étude : 1 avril 2004

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 * Patients with cutaneous metastases and previously irradiated and/or resected CNS metastases are eligible if the CNS metastases are controlled and do not require dexamethasone 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