ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter

Phase 2TerminatedNCT04668833

M.D. Anderson Cancer Center19 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor Malignancies

Interventions

Autologous lymphocyte infusion (ALI)PROCEDURE

On the day after completing the last dose of radiation therapy, the patient will have an appointment scheduled in the Apheresis Unit for the infusion of unmunipulated cryopreserved cells. Patients will be pre medicated with acetaminophen (325-650 mg PO) and diphenhydramine (12.5-25 mg PO or IV) prior to infusion. Cells will be infused without a leukoreduction filter at a rate determined by cell volume.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

To Evaluate the Absolute Lymphocyte Counts Greater or Equal to 1000 Cells/uL 6 Weeks After ALI

Absolute lymphocyte counts at week 6 (+/- 14 days) - ALC measures the actual number of lymphocytes in blood, which is to assess immune system health.

Time frame: 6 weeks +/- 14 days after ALI

Secondary Outcomes

To Evaluate the Safety of ALI in Patients Who Had Undergone Chemoradiation.

1. Grades 3-5 allergic reactions related to ALI 2. Grade 3-5 organ toxicity 3. Treatment-related death

Time frame: Baseline to 6 weeks

Data from ClinicalTrials.gov

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