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Investigator(s):
Steven A. Rosenberg, M.D., Ph.D. Principal Investigator Phone: 1-866-820-4505 (Toll Free) ncisbirc@mail.nih.gov
Referral Contact(s):
Linda Williams, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov	June A. Kryk, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov

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Primary Eligibility:

• Measurable metastatic melanoma with at least 1 lesion resectable for tumor-infiltrating lymphocytes (TIL) generation
• Patients with 1 or more brain metastasis < 1 cm each, and patients with 1 or 2 brain metastasis > 1 cm must have been treated and stable for 3 months
• ≥ 18 years of age
• ECOG 0–1
• ANC > 1,000/mm³ without filgrastim (G-CSF) support
• WBC > 3,000/mm³
• Hemoglobin > 8.0 g/dL
• Platelet count > 100,000/mm³
• HIV, hepatitis B, and hepatitis C negative
• ALT/AST < 3 x upper limit of normal (ULN)
• Creatinine ≤ 1.6 mg/dL
• Bilirubin ≤ 2 mg/dL (patients with Gilbert’s Syndrome < 3 mg/dL)
• Not pregnant or nursing; fertile patients must use effective contraception during and for 4 months after completion of study treatment
• Must have recovered from prior therapy
• No concurrent systemic steroid therapy
• No form of primary immunodeficiency
• No myocardial infarction, cardiac arrhythmias, or obstructive or restrictive pulmonary disease
• No active systemic infections, coagulation disorders, or other active major illnesses
• No severe hypersensitivity to any of the agents used in the study
• No history of coronary revascularization or ischemic symptoms

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Study Outline:

• Patients receive cyclophosphamide IV over 1 hour on Days -7 and -6, fludarabine phosphate IV over 30 minutes on Days -5 to -1, and aldesleukin IV over 15 minutes every 8 hours on Days 0–4
• Patients undergo autologous tumor-infiltrating lymphocyte infusion over 30 minutes on Day 0
• Patients also receive filgrastim (G-CSF) subcutaneously on Days 1–4 until blood counts recover
• Patients with stable disease or who have achieved a partial response or recurrence after response may receive one retreatment course beginning approximately 8 weeks after the first infusion
• Blood is collected periodically during study for research studies

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/29/09
Updated: 8/3/09