Lung Cancer Clinical Trial

ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter

Summary

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.

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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

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

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Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT04668833

Recruitment Status:

Active, not recruiting

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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M D Anderson Cancer Center
Houston Texas, 77090, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT04668833

Recruitment Status:

Active, not recruiting

Sponsor:


M.D. Anderson Cancer Center

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