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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:

• Metastatic melanoma
• Measurable disease
• Progressive or recurrent disease following previous treatment with high-dose IL-2
• ≥ 18 years of age
• Positive for MART-1 by IHC
• HLA-A* 0201 positive
• Recovered from all prior therapy
• No concurrent systemic steroid therapy
• ECOG 0–1
• ANC > 1,000/mm³ (without the support of filgrastim [G-CSF])
• WBC > 3,000/mm³
• Platelet count > 100,000/mm³
• Hemoglobin > 8.0 g/dL
• ALT/AST ≤ 2.5 x the upper limit of normal (ULN)
• Creatinine ≤ 1.6 mg/dL
• Bilirubin ≤ 1.5 mg/dL (patients with Gilbert’s Syndrome must have total bilirubin < 3.0 mg/dL)
• Not pregnant or nursing; willing to practice birth control for 4 months after receiving preparative therapy
• No active systemic infections, coagulation disorders, or other major illnesses
• No form of primary immunodeficiency
• No obstructive or restrictive pulmonary disease
• No myocardial infarction or cardiac arrhythmias
• No history of coronary revascularization or ischemic symptoms
• No severe hypersensitivity to any of the agents used in the study
• HIV, hepatitis B, and hepatitis C negative

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Treatment Plan:

Leukapheresis and cell preparation:

• Patients undergo leukapheresis to obtain peripheral blood mononuclear cells, which are subsequently cultured in the presence of anti-CD3 (OKT3) and aldesleukin
• Cells are then transduced by exposure to anti-MART-1 F5 T-cell receptor (TCR) genes and expanded in culture

Preparative regimen:

• Patients receive a preparative regimen of cyclophosphamide IV over 1 hour on Days -7 and -6 and fludarabine phosphate IV over 30 minutes on Days -5 to -1

Cell infusion:

• Patients receive autologous anti-MART-1 F5 TCR gene-engineered peripheral blood lymphocytes IV over 20–30 minutes on Day 0
• Patients also receive high-dose aldesleukin IV over 15 minutes 3 x daily beginning on Day 0 and continuing for up to 5 days (maximum of 15 doses)

• Treatment continues in the absence of disease progression
• Patients may receive one retreatment course at 6–8 weeks after the last dose of aldesleukin
• Blood is collected periodically to determine in vivo survival of TCR gene-engineered peripheral blood lymphocytes
• After completion of study therapy, patients are followed periodically for 15 years

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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.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/5/08
Updated: 9/13/07