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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
• HLA-A 0201 positive
• Progressive or recurrent disease after prior treatment with high-dose IL-2
• No concurrent systemic steroid therapy
• ≥ 18 years of age
• Adequate organ function as demonstrated by screening laboratory values
• No history of cardiac or severe respiratory disease, autoimmune disease, active viral infection, or other malignancies in past 5 years

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Treatment Plan:

Leukapheresis and cell preparation:

• Patients undergo leukapheresis to obtain peripheral blood mononuclear cells that 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

Nonmyeloablative, lymphodepleting 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

Vaccine therapy:

• Patients receive ALVAC-MART-1 vaccine subcutaneously on Days 0 (prior to peripheral blood lymphocyte infusion) and 14

Autologous gene-engineered peripheral blood lymphocyte therapy:

• Patients receive autologous anti-MART-1 F5 TCR gene-engineered peripheral blood lymphocytes IV over 20–30 minutes on Day 0

High-dose aldesleukin:

• Patients receive high-dose aldesleukin IV over 15 minutes 3 times daily on Days 0–4 (maximum of 15 doses)

• Patients with a partial response or stable disease that subsequently progresses may receive one re-treatment course (as above) beginning 6–8 weeks after the last dose of aldesleukin
• After completion of study treatment, patients are followed periodically for up to 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: 12/5/08
Updated: 2/28/08