Gene-Modified White Blood Cells Followed By Interleukin-2 and Vaccine Therapy in Treating Patients With Metastatic Melanoma
Melanoma (Skin)

About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of melanoma Metastatic disease Measurable disease Refractory to standard therapy, including high-dose interleukin-2 therapy HLA-A*0201 positive Progressive disease during prior immunization to melanoma antigens OR prior treatment with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) cellular therapy with or without myeloablation allowed provided toxicity resolved to ≤ grade 2 (except vitiligo) AND patient does not require systemic steroids No brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count > 1,000/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 8.0 g/dL Lymphocyte count > 500/mm^3 WBC > 3,000/mm^3 No coagulation disorders Hepatic AST and ALT < 3 times upper limit of normal (ULN) Bilirubin ≤ 2.0 mg/dL (3.0 mg/dL in patients with Gilbert's syndrome) Hepatitis B surface antigen negative Hepatitis C antibody negative (unless antigen negative) Renal Creatinine ≤ 1.6 mg/dL Cardiovascular LVEF ≥ 45% by cardiac stress test No LVEF < 45% in patients ≥ 50 years of age No myocardial infarction No cardiac arrhythmias No symptomatic cardiac ischemia No prior EKG abnormalities No other major cardiovascular illness Pulmonary FEV_1 ≥ 60% of predicted AND no obstructive or restrictive pulmonary disease No symptoms of respiratory dysfunction No other major respiratory illness Immunologic HIV negative Epstein-Barr virus positive No active systemic infections (including opportunistic infections) No form of primary (e.g., autoimmune colitis or Crohn's disease) or secondary immunodeficiency (due to chemotherapy or radiotherapy) No prior severe immediate hypersensitivity reaction to any of the study agents including eggs No other major illness of the immune system Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 month after study participation Willing to complete a durable power of attorney (DPA) PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics More than 6 weeks since prior MDX-010 Chemotherapy Not specified Endocrine therapy See Disease Characteristics No concurrent systemic steroid therapy Radiotherapy Not specified Surgery Not specified Other More than 4 weeks since other prior systemic therapy and recovered
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
- NCI - Surgery Branch