Cyclophosphamide and Fludarabine Followed By Interleukin-2 Gene-Modified Tumor Infiltrating Lymphocytes in Treating Patients With Metastatic Melanoma

DISEASE CHARACTERISTICS:

• Diagnosis of melanoma

  • Metastatic disease
  • Refractory to standard therapy including high-dose interleukin-2 (IL-2) therapy
• Evaluable disease
• Patients may enroll at the cell infusion stage provided they have tumor available for biopsy OR expandable SBIL-2-transduced tumor infiltrating lymphocytes available
• Progressive disease during prior immunization to melanoma antigens or cellular therapy, with or without myeloablation, allowed
• Symptomatic CNS lesions allowed provided immediate active treatment for symptomatic lesions has been completed

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count greater than 1,000/mm^3
• WBC greater than 3,000/mm^3
• Lymphocyte count greater than 500/mm^3
• Platelet count greater than 100,000/mm^3
• Hemoglobin greater than 8.0 g/dL
• No coagulation disorder

Hepatic

• Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL in patients with Gilbert's syndrome)
• AST/ALT less than 3 times upper limit of normal
• Hepatitis B surface antigen negative
• Hepatitis C virus negative

Renal

• Creatinine no greater than 1.6 mg/dL

Cardiovascular

• No myocardial infarction
• No cardiac arrhythmias
• No abnormal stress thallium or comparable test

• LVEF > 45% and normal stress cardiac test in patients with the following criteria:

  • 50 years old or greater
  • History of EKG abnormalities, symptoms of cardiac ischemia or arrhythmias
• No major cardiovascular illness

Pulmonary

• No obstructive or restrictive pulmonary disease
• No major respiratory illness
• FEV_1 > 60% predicted in patients with prolonged history of cigarette smoking or symptoms of respiratory dysfunction

Immunologic

• HIV negative
• No prior severe immediate hypersensitivity reaction
• No primary or secondary immunodeficiency
• No active systemic infection
• No concurrent opportunistic infection
• No major immune system illness

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 4 months after study therapy
• Must sign a durable power of attorney

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• No prior anti-cytotoxic T-lymphocyte antibody-4 antibody (CTLA-4) allowed unless post-MDX010 treatment and colonoscopy with colonic biopsies are normal

Chemotherapy

• Recovered from prior chemotherapy

Endocrine therapy

• No concurrent steroids

Radiotherapy

• Recovered from prior radiotherapy

Surgery

• Not specified

Other

• More than 4 weeks since prior systemic therapy