25 Participants Needed

ALI Post Radiation Therapy for Thoracic Cancers

GA
Overseen ByGheath Al-Atrash
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, any systemic therapy (treatment affecting the whole body) aside from standard immunotherapy should not be planned for at least 6 weeks after the autologous lymphocyte infusion.

What data supports the effectiveness of the treatment Autologous lymphocyte infusion (ALI) for thoracic cancers?

Research shows that tumor infiltrating lymphocytes (TIL), which are similar to the cells used in ALI, can recognize and destroy cancer cells in lung cancer. These TILs can be expanded in the lab and have shown potential in treating cancer, suggesting that ALI might be effective for thoracic cancers.12345

Is autologous lymphocyte infusion (ALI) safe for humans?

The safety of treatments combining immunotherapy and thoracic radiation therapy has been studied, showing that patients may experience immune-related side effects. However, specific safety data for autologous lymphocyte infusion (ALI) itself is not directly available from the provided research.678910

How does the ALI Post Radiation Therapy treatment for thoracic cancers differ from other treatments?

This treatment is unique because it uses adoptive immunotherapy, which involves expanding and reinfusing a patient's own tumor-infiltrating lymphocytes (TILs) to target cancer cells. Unlike traditional chemotherapy or radiation, this approach harnesses the body's immune system to specifically attack cancer cells, potentially offering a more targeted and personalized treatment option.13111213

Research Team

GA

Gheath Al-Atrash

Principal Investigator

MD Anderson Cancer Center, Houston, Texas

Eligibility Criteria

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.

Inclusion Criteria

My lung or esophageal cancer is at a stage where combined chemotherapy and radiation is recommended.
I am 18 years old or older.

Exclusion Criteria

Pregnancy
I will not start any new systemic treatments other than standard immunotherapy within 6 weeks after ALI.
I have had radiation therapy to my chest before.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation/Chemoradiation

Participants undergo radiation or chemoradiation therapy as part of their cancer treatment

6 weeks

Autologous Lymphocyte Infusion (ALI)

Participants receive autologous lymphocyte infusions to improve lymphocyte counts after radiation/chemoradiation

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Autologous lymphocyte infusion (ALI)
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Findings from Research

In a study involving 70 samples from patients with advanced non-small cell lung carcinoma (NSCLC), 46 samples of tumor-infiltrating lymphocytes (TIL) were successfully expanded in vitro, producing between 10 to 50 billion cells that effectively targeted and killed the patients' own cancer cells.
The TILs showed a preselected oligoclonal population that could be expanded while retaining their cancer-fighting properties, suggesting a promising approach for adoptive immunotherapy in patients with residual NSCLC after surgery.
Isolation and in vitro expansion of lymphocytes infiltrating non-small cell lung carcinoma: functional and molecular characterisation for their use in adoptive immunotherapy.Melioli, G., Ratto, G., Guastella, M., et al.[2019]
In a study of 96 lung cancer patients who received thoracic radiotherapy (TRT) after PD-(L)1 inhibitor treatment, nearly 49% developed symptomatic treatment-related pneumonitis, indicating a significant safety concern with this treatment sequence.
Independent risk factors for developing pneumonitis included pulmonary emphysema and lung V20 exposure, highlighting the need for careful patient selection and monitoring when using TRT after PD-(L)1 inhibitors.
Safety of thoracic radiotherapy after PD-(L)1 inhibitor treatment in patients with lung cancer.Chen, Y., Liu, X., Huang, Z., et al.[2022]
In a study of 60 patients receiving combined immunotherapy and thoracic radiation therapy (iRT), no patients experienced severe grade ≥4 toxicities, indicating a favorable safety profile for this treatment approach.
While some patients did experience grade 3 toxicities, particularly pulmonary and hematologic issues, the overall short-term safety of iRT suggests it can be administered without significant risk of severe adverse effects.
Safety of Combined Immunotherapy and Thoracic Radiation Therapy: Analysis of 3 Single-Institutional Phase I/II Trials.Verma, V., Cushman, TR., Selek, U., et al.[2022]

References

Isolation and in vitro expansion of lymphocytes infiltrating non-small cell lung carcinoma: functional and molecular characterisation for their use in adoptive immunotherapy. [2019]
[Clinical research on the antitumor activity and phenotype of tumor infiltrating lymphocytes for treatment of lung cancer]. [2010]
Harnessing T-lymphocytes for human cancer immunotherapy. [2019]
Lymphocyte replication in lung cancer patients undergoing radiotherapy. [2018]
Risk of on-treatment lymphopenia is associated with treatment outcome and efficacy of consolidation immunotherapy in patients with non-small cell lung cancer treated with concurrent chemoradiotherapy. [2023]
Safety of thoracic radiotherapy after PD-(L)1 inhibitor treatment in patients with lung cancer. [2022]
First-line atezolizumab/durvalumab plus platinum-etoposide combined with radiotherapy in extensive-stage small-cell lung cancer. [2023]
Safety of Combined Immunotherapy and Thoracic Radiation Therapy: Analysis of 3 Single-Institutional Phase I/II Trials. [2022]
Positive Correlation of Peripheral CD8+ T Lymphocytes with Immune-Related Adverse Events and Combinational Prognostic Value in Advanced Non-Small Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors. [2023]
The effective radiation dose to immune cells predicts lymphopenia and inferior cancer control in locally advanced NSCLC. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Derivation of tumor-specific cytolytic T-cell clones from two lung cancer patients with long survival. [2006]
12.United Statespubmed.ncbi.nlm.nih.gov
Immunotherapy with the use of tumor-infiltrating lymphocytes and interleukin-2 as adjuvant treatment in stage III non-small-cell lung cancer. A pilot study. [2004]
On the safety assurance of cell processing carried out in medical institutions for autologous immuno-cell therapy. [2019]