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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 one of the following digestive tract carcinomas: gastric, gastroesophageal, pancreatic, hepatocellular, colorectal, and gallbladder, or cholangiocarcinoma
• Metastatic disease (Stage IV)
• At least one lesion that is resectable for tumor infiltrating lymphocytes (TIL) generation
• ≥ 18 years of age
• Refractory to approved standard systemic therapy
• Metastatic colorectal patients must have received 5-FU and leucovorin in combination with either oxaliplatin and/or irinotecan
• Hepatocellular carcinoma patients must have received sorafenib
• ECOG ≤ 1
• No contraindications to aldesleukin administration
• No concurrent major medical conditions or any form of immunodeficiency

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Study Outline:

• Patients will undergo resection to obtain tumor for generation of tumor infiltrating lymphocytes (TIL)
• Following successful generation of the TIL product, patients 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 begin high-dose aldesleukin every 8 hours for up to 15 doses
• Patients will return to the Clinical Center for evaluation about 4–6 weeks after TIL infusion

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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, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/14/12
Updated: 8/18/10