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ALI Post Radiation Therapy for Thoracic Cancers

Phase 2

Waitlist Available

Led By Gheath Al-Atrash

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Age 18

Must not have

Prior radiotherapy to the chest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if giving patients their own lymphocytes (a type of white blood cell) after chemotherapy and radiation treatment for lung or esophageal cancer is safe and effective.

Who is the study for?

This trial is for adults over 18 with non-small cell lung cancer or esophageal cancer at stages II-IVA, where chemoradiation is standard. Participants must not have had prior chest radiotherapy, any systemic therapy other than standard immunotherapy before 6 weeks after ALI, be pregnant, or have a life expectancy under 6 months.

What is being tested?

The study tests the safety and effectiveness of autologous lymphocyte infusion (ALI) in patients receiving chemotherapy and radiation for lung or esophageal cancer. It aims to understand if this approach improves treatment outcomes.

What are the potential side effects?

While specific side effects are not listed here, treatments like ALI may cause immune reactions, fatigue, infection risk increase due to immune system changes from infusions alongside typical chemotherapy and radiation side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung or esophageal cancer is at a stage where combined chemotherapy and radiation is recommended.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had radiation therapy to my chest before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate the absolute lymphocyte counts in lung and esophageal cancer patients who had undergone chemoradiation. (CRT)

Secondary study objectives

To evaluate the feasibility of ALI in patients who had undergone chemoradiation.

To evaluate the safety of ALI in patients who had undergone chemoradiation.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Autologous Lymphocyte Infusions)Experimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met