Esophageal Cancer Clinical Trial
Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation
Summary
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.
Eligibility Criteria
Inclusion Criteria:
Group 1A
a. Participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons.
Group 1B
a. Participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT)
Group 2A
a. Participants currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable hepatocellular carcinoma.
Group 2B
a. Participants 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
Participants 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:
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
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