This phase II trial studies how well tumor infiltrating lymphocytes and aldesleukin work in treating patients with biliary tract cancers that has spread to other places in the body, has come back, or does not respond to treatment. Tumor infiltrating lymphocytes are a type of white blood cells which are taken from patients' tumors, grown in the laboratory in large numbers, and then given back to the patient to fight the tumor. Before receiving the cells, chemotherapy drugs called cyclophosphamide and fludarabine are given to temporarily suppress the immune system to improve the chances that the tumor fighting cells will be able to survive in the body. After the cells are given, aldesleukin may help the tumor fighting cells stay alive longer. This study is being done to see if giving tumor infiltrating lymphocytes and aldesleukin will cause biliary tract tumors to shrink.
Additional locations may be listed on ClinicalTrials.gov for NCT03801083.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Contact: Udai S. Kammula
Phone: 412-623-7712
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous tumor infiltrating lymphocyte (TIL) and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic biliary tract cancer using the objective response rate (ORR).
SECONDARY OBJECTIVES:
I. To further evaluate the efficacy of this therapy using complete response (CR) rate, duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
II. To characterize the safety profile of this therapy in patients with locally advanced, recurrent, or metastatic biliary tract cancer.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive cyclophosphamide intravenously (IV) over 1 hour on days -7 to -6 and fludarabine IV over 30 minutes on days -5 to -1.
INFUSION: Patients undergo adoptive transfer of autologous TILs IV over 20-30 minutes on day 0. Within 24 hours, patients receive aldesleukin IV over 15 minutes every 8 hours for up to 6 doses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 and 12 weeks, every 3 months for 9 months, and every 6 months for 1 year.
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorUdai S. Kammula