Chemoradiation, Esophageal Cancer, Lymphopenia, Pneumococcal Vaccine
Conditions
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 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
BIOLOGICALPneumonia vaccine
Given by SC
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Group 1A a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons. 2. Group 1B a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT) 3. Group 2A a. Patients currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable liver cancer. 4. Group 2B a. Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable liver cancer. 5. Group 3 a. Healthy age- and gender- matched individuals 6. All Groups 1. Patients 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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination | 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. |
Countries
United States
Contacts
CONTACTSteven H Lin, MD
PRINCIPAL_INVESTIGATORSteven H Lin, MD
M.D. Anderson Cancer Center
Outcome results
None listed