ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter

  • STATUS
    Recruiting
  • days left to enroll
    63
  • participants needed
    20
  • sponsor
    M.D. Anderson Cancer Center
Updated on 4 October 2022
Accepts healthy volunteers

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.

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.

Details
Condition Solid Tumor Malignancies
Treatment Autologous lymphocyte infusion (ALI)
Clinical Study IdentifierNCT04668833
SponsorM.D. Anderson Cancer Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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