Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma That Has Not Responded to Previous Treatment
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of metastatic melanoma Refractory to standard therapy No resectable locoregional disease HLA-A0201 positive Measurable disease Previously resected brain metastases, brain metastases stable after prior radiosurgery, or brain metastases less than 1 cm and without edema allowed PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 90,000/mm^3 No coagulation disorders Hepatic: Bilirubin no greater than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome) AST/ALT less than 3 times normal Hepatitis B surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major medical illness of the cardiovascular system No cardiac ischemia* No myocardial infarction* No cardiac arrhythmias* NOTE: * For interleukin-2 (IL-2) administration Pulmonary: No major medical illness of the respiratory system No obstructive or restrictive pulmonary disease (for IL-2 administration) Immunologic: HIV negative No primary or secondary immunodeficiency No known immunodeficiency disease No autoimmune disease No active systemic infections Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy for melanoma No prior immunization to tyrosinase-related protein-2 antigen No other concurrent biologic therapy for melanoma Chemotherapy: At least 3 weeks since prior chemotherapy for melanoma and recovered No concurrent chemotherapy for melanoma Endocrine therapy: At least 3 weeks since prior endocrine therapy for melanoma No concurrent systemic steroid therapy No concurrent endocrine therapy for melanoma Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy for melanoma and recovered No concurrent radiotherapy for melanoma Surgery: See Disease Characteristics Other: No other concurrent therapy for melanoma
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support