ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter

M.D. Anderson Cancer Center

Status and phase: Terminated; Phase 2

Conditions: Solid Tumor Malignancies

Treatments: Procedure: Autologous lymphocyte infusion (ALI)

Study type: Interventional

Funder types: Other

Identifiers

NCT04668833

2019-1164

NCI-2020-07836 (Other Identifier)

Details and patient eligibility

About

The goal of this clinical research study is to learn if giving autologous lymphocyte infusions to patients who are receiving chemotherapy and radiation for non-small cell lung cancer or esophageal cancer is safe and effective.

Full description

The purpose of this study is to determine the safety and preliminary efficacy of un-manipulated autologous lymphocyte infusion (ALI) using the patient's own lymphocytes collected using apheresis, and infused after the completion of radiation/chemoradiation. Primary Objective To investigate the preliminary efficacy of autologous lymphocyte infusion (ALI) in improving the absolute lymphocyte counts in lung and esophageal cancer patients who had undergone chemo-radiation (CRT). Secondary Objectives

1. To evaluate the feasibility and safety of ALI in patients who had undergone chemoradiation.
2. To identify lymphocyte clonal populations in the tissue that are specific for tumor cells
3. To identify immune reconstitution in the peripheral blood shaped by ALI.
4. To conduct clonal analysis using T-cell receptor (TCR) sequencing from tumor and from peripheral blood.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Histologically or cytologically documented NSCLC or esophageal cancers Stage II-IVA disease where definitive chemoradiation is the standard of care Age 18

Exclusion criteria

Prior radiotherapy to the chest Life expectancy<6 months Any systemic therapy, aside from standard of care immunotherapy, that is planned to be administered prior to 6 weeks after ALI. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Treatment (Autologous Lymphocyte Infusions)

Experimental group

Description:

The purpose of this study is to determine the safety and preliminary efficacy of un-manipulated autologous lymphocyte infusion (ALI) using the patient's own lymphocytes collected using apheresis, and infused after the completion of radiation/chemoradiation.

Treatment:

Procedure: Autologous lymphocyte infusion (ALI)