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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Lymphopenia; Esophageal Cancer; Chemoradiation; Pneumococcal Vaccine

Treatments: Biological: Pneumonia vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT06181656

NCI-2023-10646 (Other Identifier)

2023-0370

Details and patient eligibility

About

To learn how radiation treatment may affect your responses to vaccines against pneumonia.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 hepatocellular carcinoma.

4. Group 2B

   a. Patients 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. 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

Trial design

80 participants in 3 patient groups

Group 1

Description:

30 participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer. This group will be subdivided into Group 1A, which will comprise 15 participants treated with proton therapy, and Group 1B, which will comprise 15 patients treated with intensity modulated radiation therapy (IMRT).

Treatment:

Biological: Pneumonia vaccine

Group 2

Description:

30 participants currently receiving, planning to receive, or recently completed chemoradiation for hepatocellular carcinoma. This group will be subdivided into Group 2A, which will comprise 15 participants treated with proton therapy, and Group 2B, which will comprise 15 patients treated with intensity modulated radiation therapy (IMRT).

Treatment:

Biological: Pneumonia vaccine

Group 3

Description:

20 Healthy Volunteers.

Treatment:

Biological: Pneumonia vaccine