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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181656
• Other study ID #: 2023-0370
• Secondary ID: NCI-2023-10646
• Status: Recruiting
• Start date: February 5, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Steven H Lin, MD
• Phone: (713) 563-8490
• Email: shlin[@]mdanderson.org
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Chemoradiation
• Esophageal Cancer
• Esophageal Neoplasms
• Lymphopenia
• Pneumococcal Vaccine

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

External Links

•   MD Anderson Cancer Center