Infusing immune cells to treat biliary tract cancers
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
This study is testing if infusing immune cells from a patient's own tumors, along with a special medication, can help people with advanced biliary tract cancers feel better and improve their condition.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 59 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, fludarabine |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT03801083 on ClinicalTrials.gov |
What this trial studies
This Phase 2 study evaluates the effectiveness of infusing autologous Tumor Infiltrating Lymphocytes (TIL) combined with high-dose aldesleukin in patients with advanced biliary tract cancers. Participants will undergo a preparative regimen of non-myeloablative chemotherapy before receiving the TIL infusion. The study aims to assess the objective response rate in patients with locally advanced, recurrent, or metastatic biliary tract cancers, including cholangiocarcinoma and gallbladder cancer. The trial includes a companion protocol for the preparation of TIL from tumor samples.
Who should consider this trial
Good fit: Ideal candidates are patients with measurable locally advanced, recurrent, or metastatic biliary tract carcinoma who are physically able to tolerate the treatment regimen.
Not a fit: Patients with biliary tract cancers that are resectable by conventional surgical approaches or those who have not been refractory to standard systemic therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with poor prognosis biliary tract cancers.
How similar studies have performed: While this approach is innovative, similar studies using TIL therapy have shown promise in other cancer types, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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) Exclusion Criteria: * 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.
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Udai S Kammula,, MD — UPMC Hillman Cancer Center
- Study coordinator: Josh Tobin
- Email: tobinja@upmc.edu
- Phone: 412-864-7754
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.