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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:

• Confirmed diagnosis of metastatic melanoma that progressed or recurred following treatment with high-dose IL-2
• Measurable disease
• Positive for gp100 by IHC
• HLA-A 0201 positive
• Recovered from prior therapy
• No concurrent systemic steroid therapy
• ≥ 18 years of age
• ECOG 0–1
• ANC > 1,000/mm³
• 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; fertile patients must use effective contraception for 4 months after preparative regimen
• HIV, hepatitis B, and hepatitis C negative
• No concurrent major illnesses
• No form of primary immunodeficiency or opportunistic infections
• No history of coronary revascularization
• No severe hypersensitivity to any of the agents used in the study

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Study Outline:

Leukapheresis and cell preparation:

• Patients undergo leukapheresis to obtain peripheral blood mononuclear cells, if tumor-infiltrating lymphocytes (TIL) are not available
• The anti-gp100:154 T-cell receptor (TCR) genes are put in the cells and the cells expanded in culture

Preparative regimen:

• Patients receive 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-gp100:154-162 T-cell receptor (TCR) gene-engineered peripheral blood lymphocytes or TIL IV over 20–30 minutes on Day 0
• Patients also receive aldesleukin IV over 15 minutes 3 x daily beginning on Day 0 and continuing for up to 5 days

• Patients may receive 1 retreatment course 6–8 weeks after the last aldesleukin dose
• Blood is collected periodically to determine in vivo survival of TCR gene-engineered cells via PCR and immunological laboratory methods
• After completion of study treatment, 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.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/29/09
Updated: 8/3/09