Interferon Beta in Treating Patients With Metastatic Cutaneous Melanoma or Ocular Melanoma
Stage IV Melanoma, Recurrent Melanoma
About this trial
This is an interventional treatment trial for Stage IV Melanoma focused on measuring recurrent melanoma, stage IV melanoma, iris melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma
Eligibility 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 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
Sites / Locations
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Recombinant interferon beta