Clinical trial NCT06181656: Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation
Official title: Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumococcal Vaccine
Esophageal Cancer
Lymphopenia
Chemoradiation
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center will enroll 30 esophageal cancer patients. Massachusetts General Hospital in Boston, MA will enroll 30 HCC patients. MD Anderson Cancer Center \& Massachusetts General Hospital in Boston will jointly enroll up to 20 health volunteers.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination
timeFrame: through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Steven H Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: