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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06181656
Other study ID # 2023-0370
Secondary ID NCI-2023-10646
Status Recruiting
Phase
First received
Last updated
Start date February 5, 2024
Est. completion date September 30, 2025

Study information

Verified date May 2024
Source M.D. Anderson Cancer Center
Contact Steven H Lin, MD
Phone (713) 563-8490
Email shlin@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To learn how radiation treatment may affect your responses to vaccines against pneumonia.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date September 30, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Biological:
Pneumonia vaccine
Given by SC

Locations

Country Name City State
United States MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination 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
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