RECRUITING

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers

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 of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic cancer associated with one of the following cancer types: 1.) gastric/esophagogastric, 2.) colorectal, 3.) pancreatic, 4.) sarcoma, 5.) mesothelioma, 6.) neuroendocrine, 7.) squamous cell cancer, 8.) Merkle cell, 9.) mismatch repair deficient and/or microsatellite unstable cancers, and 10.) patients who have exhausted conventional systemic therapy options by using the objective response rate (ORR).

Official Title

A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients With Advanced Solid Cancers

Quick Facts

Study Start:2019-12-03
Study Completion:2037-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03935893

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 CriteriaExclusion Criteria
  1. * 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.)
  2. * Seronegative for hepatitis B antigen
  3. * 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.
  4. * Absolute neutrophil count greater than 1000/mm3 without the support of filgrastim
  5. * WBC ≥ 3000/mm3
  6. * Platelet count ≥ 100,000/mm3
  7. * Hemoglobin \> 8.0 g/dl
  8. * Serum ALT/AST ≤ to 3.5 times the upper limit of normal Serum creatinine ≤ to 1.6 mg/dl
  9. * 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.
  1. * Age \> 65 years' old
  2. * 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.
  3. * A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2 years).
  4. * Symptoms of respiratory dysfunction

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 Date2019-12-03
Study Completion Date2037-06-30

Study Record Updates

Study Start Date2019-12-03
Study Completion Date2037-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Gastric Cancer
  • Colorectal Cancer
  • Pancreatic Cancer
  • Sarcoma
  • Mesothelioma
  • Neuroendocrine Tumors
  • Squamous Cell Cancer
  • Merkel Cell Carcinoma
  • Mismatch Repair Deficiency
  • Microsatellite Instability