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

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