Eligibility Criteria

Patients with histologically proven metastatic melanoma, with at least two measurable target lesions ≥ 1 cm on cross-sectional imaging and Eastern Cooperative Oncology Group performance status < 2 were eligible for screening and metastectomy for TIL. All patients were age ≥ 18 years with a life expectancy > 3 months and with adequate hepatic, renal, and bone marrow function and clear demonstration of progression of disease ≥ 4 weeks after any prior therapy. Exclusion criteria included contraindications to TBI, autoimmune disorders that required immunosuppressive therapy, or any active disease that would preclude the administration of IL-2. Before enrollment, TIL generated from patient tumors had to demonstrate growth in culture sufficient to reach quantities necessary for treatment. All patients provided written informed consent approved by the Institutional Review Board of the National Cancer Institute.