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Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers

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).

Conditions

Gastric CancerColorectal CancerPancreatic CancerSarcomaMesotheliomaNeuroendocrine TumorsSquamous Cell CancerMerkel Cell CarcinomaMismatch Repair DeficiencyMicrosatellite Instability
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Related Conditions:

Gastric CancerColorectal CancerPancreatic CancerSarcomaMesotheliomaNeuroendocrine TumorsSquamous Cell CancerMerkel Cell CarcinomaMismatch Repair DeficiencyMicrosatellite Instability

Study Overview

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Study Details

Study overview

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).

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

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers

Condition
Gastric Cancer
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States, 15232

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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.
  • * 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
  • * 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.
  • * 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.
  • * A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2 years).
  • * Symptoms of respiratory dysfunction

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Udai Kammula,

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

Study Record Dates

2037-06-30