Status:
RECRUITING
Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Pneumococcal Vaccine
Esophageal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
To learn how radiation treatment may affect your responses to vaccines against pneumonia.
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 chemoradiatio...
Eligibility Criteria
Inclusion
- Group 1A
- a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons.
- Group 1B
- a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT)
- Group 2A
- a. Patients currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable hepatocellular carcinoma.
- Group 2B
- a. Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable hepatocellular carcinoma.
- Group 3
- a. Healthy age- and gender- matched individuals
- All Groups
- Patients of all genders, races and nationalities will be solicited.
- Age \>18 years
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients 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.
- Patients receiving intravenous immunoglobulin (IVIG) during the study or in the three months prior to study enrollment.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Individuals with previous pneumococcal vaccination in the last 5 years.
- Individuals with severe allergy to any of the vaccine components
Key Trial Info
Start Date :
February 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06181656
Start Date
February 5 2024
End Date
September 30 2025
Last Update
August 8 2025
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030