Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers

Inclusion Criteria

• •Measurable locally advanced, recurrent, or metastatic biliary tract carcinoma (including intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma).
• •Patients with locally advanced disease should be unresectable by conventional surgical approaches.
• •Patients with distant metastatic spread must be refractory to approved standard systemic therapies (such as gemcitabine, cisplatin, or equivalents) if they are eligible to receive these treatments.
• •Patients must be co-enrolled on the companion protocol HCC 17-220 (Cell Harvest and Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical Studies) and have available TIL cultures for therapy.
• •Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.
• •Greater than or equal to 18 years of age and less than or equal to age 75
• •Able to understand and sign the Informed Consent Document
• •Clinical performance status of ECOG 0 or 1
• •Life expectancy of greater than three months
• •Patients of both genders who are of child-bearing potential must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the treatment.
• •Serology:
• •* Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)
• •* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
• •Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus.
• •Hematology
• •* Absolute neutrophil count greater than 1000/mm3 without the support of filgrastim
• •* WBC ≥ 3000/mm3
• •* Platelet count ≥ 100,000/mm3
• •* Hemoglobin \> 8.0 g/dl
• •Chemistry
• •* Serum ALT/AST ≤ to 3.5 times the upper limit of normal
• •* Serum creatinine ≤ to 1.6 mg/dl
• •* Total bilirubin ≤ to 2.0 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
• •More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a clinically manageable level (except for toxicities such as alopecia or vitiligo). (Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less)