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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:

• Diagnosis of metastatic melanoma
• Previously treated with high-dose aldesleukin AND developed progressive or recurrent disease after treatment
• Measurable disease
• gp100 positive tumor by immunohistochemistry
• HLA-A*0201 positive
• 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
• Not pregnant or nursing
• HIV, hepatitis B, and hepatitis C negative

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Study Outline:

Leukapheresis and cell preparation:

• Patients undergo leukapheresis to obtain peripheral blood mononuclear cells
• Cells are then genetically modified and grown in the laboratory

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-gp100 vaccine subcutaneously on Day 0 (prior to anti-gp100 cell infusion) and Day 14

Autologous gene-engineered peripheral blood lymphocyte therapy:

• Patients receive anti-gp100 cells IV over 20–30 minutes on Day 0

High-dose aldesleukin:

• Patients receive high-dose aldesleukin IV over 15 minutes every 8 hours on Days 0–4 (total of 15 doses)

• Patients with a partial response to treatment 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 therapy, 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.
• 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: 6/29/09
Updated: 7/27/09