RECRUITING

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers

Conditions

Biliary Tract Cancer Cholangiocarcinoma Biliary Tract Neoplasms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 2 study to evaluate the efficacy, using objective response rate, of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous Tumor Infiltrating Lymphocytes (TIL) and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic biliary tract cancer. These are low-incidence cancers carry a poor prognosis. Participants will include patients with biliary tract cancers (BTC), including cholangiocarcinoma (both intrahepatic and extrahepatic) and gallbladder cancer, who are and are physically able to tolerate non-myeloablative chemotherapy and high-dose aldesleukin.

Official Title

A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients With Locally Advanced, Recurrent, or Metastatic Biliary Tract Cancers

Quick Facts

Study Start:2019-02-19

Study Completion:2030-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03801083

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant. * Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). * Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). * Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses. * History of clinically significant major organ autoimmune disease * Concurrent systemic steroid therapy. * History of severe immediate hypersensitivity reaction to any of the agents used in this study. * History of active coronary or ischemic symptoms. * Documented LVEF of less than or equal to 45%; note: testing is required in patients with: * Age \> 65 years' old * Clinically significant atrial and or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or have a history of ischemic heart disease, chest pain. * Documented FEV1 less than or equal to 60% predicted tested in patients with: * A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2 years). * Symptoms of respiratory dysfunction * Patients who are receiving any other investigational agents.

Inclusion Criteria

Exclusion 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)

* Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
* Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses.
* History of clinically significant major organ autoimmune disease
* Concurrent systemic steroid therapy.
* History of severe immediate hypersensitivity reaction to any of the agents used in this study.
* History of active coronary or ischemic symptoms.
* Documented LVEF of less than or equal to 45%; note: testing is required in patients with:
* Age \> 65 years' old
* Clinically significant atrial and or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or have a history of ischemic heart disease, chest pain.
* Documented FEV1 less than or equal to 60% predicted tested in patients with:
* A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2 years).
* Symptoms of respiratory dysfunction
* Patients who are receiving any other investigational agents.

Contacts and Locations

Study Contact

Josh Tobin

CONTACT

412-864-7754

tobinja@upmc.edu

Allyson Welsch

CONTACT

412-623-6763

welscha2@upmc.edu

Principal Investigator

Udai S Kammula,, MD

PRINCIPAL_INVESTIGATOR

UPMC Hillman Cancer Center

Study Locations (Sites)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Collaborators and Investigators

Sponsor: Udai Kammula

Udai S Kammula,, MD, PRINCIPAL_INVESTIGATOR, UPMC Hillman Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-02-19

Study Completion Date2030-01-31

Study Record Updates

Study Start Date2019-02-19

Study Completion Date2030-01-31

Terms related to this study

Keywords Provided by Researchers

Biliary Tract Cancer
Cholangiocarcinoma

Additional Relevant MeSH Terms

Biliary Tract Cancer
Cholangiocarcinoma
Biliary Tract Neoplasms