Monoclonal Antibody Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma
Intraocular Melanoma, Melanoma (Skin)

About this trial
This is an interventional treatment trial for Intraocular Melanoma focused on measuring stage IV melanoma, extraocular extension melanoma, recurrent melanoma, iris melanoma, ciliary body and choroid melanoma, medium/large size, ciliary body and choroid melanoma, small size, recurrent intraocular melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IV melanoma Mucosal or ocular melanoma also eligible Clinically evaluable disease At least 1 site of measurable disease PATIENT CHARACTERISTICS: Age 16 and over Performance status ECOG 0-1 Life expectancy At least 3 months Hematopoietic WBC at least 2,500/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hematocrit at least 30% Hepatic Bilirubin no greater than upper limit of normal (ULN)* (less than 3.0 mg/dL in patients with Gilbert's syndrome) AST no greater than 3 times ULN* Hepatitis B surface antigen negative Hepatitis C antibody nonreactive No evidence or history of significant hepatic disease that would preclude safe administration of high-dose IL-2 NOTE: *Unless attributable to disease Renal Creatinine no greater than 2.0 mg/dL No evidence or history of significant renal disease that would preclude safe administration of high-dose IL-2 Cardiovascular No evidence or history of significant cardiac disease that would preclude safe administration of high-dose IL-2 Thallium stress test normal (for patients over 50 years of age or with a history of cardiovascular disease) Pulmonary No evidence or history of significant pulmonary disease that would preclude safe administration of high-dose IL-2 Immunologic HIV negative No autoimmune disease (including uveitis and autoimmune inflammatory eye disease) No active infection Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix No evidence or history of significant gastrointestinal disease that would preclude safe administration of high-dose IL-2 No evidence or history of psychiatric disease that would preclude safe administration of high-dose IL-2 No other underlying medical condition that would make the administration of the study drug hazardous or obscure the interpretation of adverse events No other concurrent medical condition that would preclude study entry PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 weeks since prior immunotherapy for melanoma and recovered No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) No prior high-dose (at least 600,000 IU/kg every 8 hours) interleukin-2 (IL-2) Chemotherapy At least 3 weeks since prior chemotherapy for melanoma and recovered No concurrent chemotherapy Endocrine therapy At least 3 weeks since prior hormonal therapy for melanoma and recovered At least 4 weeks since prior corticosteroids No concurrent systemic or topical corticosteroids Radiotherapy At least 3 weeks since prior radiotherapy for melanoma and recovered Surgery Not specified Other No concurrent immunosuppressive agents (e.g., cyclosporine or its analog)
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support