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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:

• Diagnosis of metastatic melanoma
• Measurable disease with at least one lesion that is resectable for tumor infiltrating lymphocytes (TIL) generation; the lesion must be of at least 2 cm in diameter and able to be surgically removed with minimal morbidity (defined as any operation for which expected hospitalization is fewer than or equal to 7 days)
• ≥ 18 years of age
• ECOG ≤ 1
• No concurrent major medical illnesses or any form of immunodeficiency
• No contraindications for high dose IL-2 administration

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Study Outline:

• Screening physical examination; blood and tumor samples; and imaging studies to determine eligibility for the study
• Patients undergo leukapheresis to obtain certain types of blood cells
• Generation of autologous young tumor infiltrating lymphocytes (TIL) cultures cultured from the patient’s tumor cells obtained either from a biopsy or during surgery
• Parallel TIL cultures will be established using:
• The standard technique with IL-2 only
• Engineered cells with costimulation enhancement (ECCE)
• All TIL cultures will be expanded to large numbers in the presence of ECCE cells
• Following successful generation of TIL*, admission 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 begin high-dose aldesleukin every 8 hours for up to 15 doses
• Return to the clinic for a physical exam, review of side effects, labs, and scans every
  4–6 weeks for the first year, and then every 6 months

* Standard TIL will be used preferentially, and patients who have TIL established by standard methods will be assigned to group 1. If standard young TIL fail to grow, then ECCE young TIL will be evaluated, and patients who have ECCE TIL available will be assigned to group 2.

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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