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

Inclusion 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