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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):
June A. Kryk, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov	Linda Williams, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov

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Key Eligibility Criteria:

• Measurable metastatic melanoma that expresses the VtoE BRAF mutation assessed in a CLIA certified laboratory
• ≥ 18 years of age
• ECOG ≤ 1
• No concurrent major medical illnesses or any form of immunodeficiency
• No previous treatment with vemurafenib
• Able to swallow whole tablets

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Study Outline:

• Screening physical examination; blood and tumor samples; and imaging studies to determine eligibility for the study
• Tumor Infiltrating lymphocytes (TIL) are collected from a melanoma metastasis by surgery or biopsy and grown in the laboratory
• Patients undergo leukapheresis to collect other white blood cells
• Vemurafenib tablets by mouth twice a day, starting 3 weeks before receiving the TIL
• Following successful generation of the tumor infiltrating lymphocytes (TIL), the patient will be admitted to the NIH Clinical Center to begin treatment with a non-myeloablative lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine
• After completion of the preparative regimen, patients will receive the infusion of TIL and then IL-2 every 8 hours for up to 15 doses
• Return to the clinic for a physical exam, review of side effects, and labs every 1 to 3 months until off study criteria are met

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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: 12/14/12
Updated: 6/19/12