Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation

February 6, 2024 updated by: M.D. Anderson Cancer Center
To learn how radiation treatment may affect your responses to vaccines against pneumonia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives

- Determine the impact of Grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination.

Secondary Objectives

  • Determine the impact of chemoradiation on serologic responses to pneumococcal vaccination.
  • Determine the impact of radiation modality on serologic responses to pneumococcal vaccination.
  • Determine the impact of radiation modality on systemic immunity.
  • Determine the incidence of pneumonia among patients treated with a pneumococcal vaccine.
  • Determine the impact of radiation modality on pathologic response.
  • Determine the impact of radiation modality on intratumoral immunity.
  • Determine the relationship between changes in systemic and intratumoral immunity and clinical outcomes (i.e., incidence of pneumonia and pathologic response)
  • Determine the impact of tumor histology on serologic responses to pneumococcal vaccination.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

MD Anderson Cancer Center will enroll 30 esophageal cancer patients. Massachusetts General Hospital in Boston, MA will enroll 30 HCC patients. MD Anderson Cancer Center & Massachusetts General Hospital in Boston will jointly enroll up to 20 health volunteers.

Description

Inclusion Criteria:

  1. Group 1A

    a. Participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons.

  2. Group 1B

    a. Participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT)

  3. Group 2A

    a. Participants currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable hepatocellular carcinoma.

  4. Group 2B

    a. Participants currently receiving, planning to receive, or recently completed definitive IMRT for unresectable hepatocellular carcinoma.

  5. Group 3

    a. Healthy age- and gender- matched individuals

  6. All Groups

    1. Participants of all genders, races and nationalities will be solicited.
    2. Age >18 years
    3. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants with compromised immunologic responses due to an uncontrolled intercurrent immunodeficiency (e.g., Human immunodeficiency virus (HIV), X-linked agammaglobulinemia) or previous or current immune suppressive therapy

    a. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

  • Participants receiving intravenous immunoglobulin (IVIG) during the study or in the three months prior to study enrollment.
  • Participants with psychiatric illness/social situations that would limit compliance with study requirements.
  • Participants with previous pneumococcal vaccination
  • Participants with severe allergy to any of the vaccine components

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
30 participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer. This group will be subdivided into Group 1A, which will comprise 15 participants treated with proton therapy, and Group 1B, which will comprise 15 patients treated with intensity modulated radiation therapy (IMRT).
Biological: Pneumonia vaccine
Given by SC
Group 2
30 participants currently receiving, planning to receive, or recently completed chemoradiation for hepatocellular carcinoma. This group will be subdivided into Group 2A, which will comprise 15 participants treated with proton therapy, and Group 2B, which will comprise 15 patients treated with intensity modulated radiation therapy (IMRT).
Biological: Pneumonia vaccine
Given by SC
Group 3
20 Healthy Volunteers.
Biological: Pneumonia vaccine
Given by SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination
Time Frame: through study completion; an average of 1 year
Serologic responses will be calculated as the average fold change in antibody titer for each of 20 pneumococcal serotypes between baseline (time 0) and the first post-vaccination blood draw.
through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Steven H Lin, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0370
  • NCI-2023-10646 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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