Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pneumonia vaccine.
- Who it may be relevant to
- Registry conditions: Pneumococcal Vaccine, Esophageal Cancer, Lymphopenia, Chemoradiation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 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.
Interventions
- Biological Pneumonia vaccine
Given by SC
Primary outcome measures
- Impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination [Time frame: through study completion; an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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 liver cancer.
- Group 2B
a. Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable liver cancer.
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06181656 · 2023-0370 · NCI-2023-10646