Laboratory-Treated Autologous Lymphocytes and Aldesleukin After Cyclophosphamide and Fludarabine in Treating Patients With Metastatic Melanoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Diagnosis of metastatic melanoma
• •Refractory to standard treatment including high-dose aldesleukin (IL-2), unless previously ineligible for or refused IL-2
• •Measurable disease with ≥ 1 lesion that is resectable for tumor-infiltrating lymphocyte generation
• •Patients with ≥ 1 brain metastases \< 1 cm each, or 1-2 brain metastases \> 1 cm are eligible provided they have been treated and stable for ≥ 3 months
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-1
• •Life expectancy \> 3 months
• •ANC \> 1,000/mm\^3 (without filgrastim support)
• •WBC \> 3,000/mm\^3
• •Hemoglobin \> 8.0 g/dL
• •Platelet count \> 100,000/mm\^3
• •Serum ALT/AST \< 3 times upper limit of normal
• •Total bilirubin ≤ 2 mg/dL (\< 3 mg/dL in patients with Gilbert's syndrome)
• •Serum creatinine ≤ 1.6 mg/dL
• •LVEF \> 45% in patients meeting the following criteria:
• •* Clinically significant atrial and/or ventricular arrhythmias, including, but not limited to, atrial fibrillation, ventricular tachycardia, or second- or third-degree heart block
• •* At least 60 years of age
• •FEV\_1 \> 60% in patients meeting the following criteria:
• •* Prolonged history of cigarette smoking
• •* Symptoms of respiratory dysfunction
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 4 months after completion of study treatment
• •No HIV or hepatitis B or C positivity
• •No form of primary immunodeficiency (e.g., severe combined immunodeficiency disease or AIDS)
• •No opportunistic infections
• •No active systemic infections
• •No history of severe immediate hypersensitivity reaction to any of the agents used in this study
• •No coagulation disorders
• •No myocardial infarction, cardiac arrhythmias, or positive stress thallium or comparable test
• •No history of coronary revascularization or ischemic symptoms
• •No obstructive or restrictive pulmonary disease
• •No other active major medical illness of the cardiovascular, respiratory, or immune system
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •Recovered from prior therapy (alopecia or vitiligo allowed)
• •At least 6 weeks since prior ipilimumab
• •* Must have normal colonoscopy with normal colonic biopsies
• •At least 4 weeks since prior systemic therapy
• •Minor surgical procedures within the past 3 weeks allowed provided all toxicities have recovered to ≤ grade 1
• •No concurrent systemic steroids
• •No other concurrent experimental agents