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Gastrointestinal Neoplasms

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Gastrointestinal Diseases

Esophageal Diseases

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Leukocyte Disorders

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Vaccines

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).

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).

Pneumonia vaccine

Steven H Lin, MD

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

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.

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

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.

M.D. Anderson Cancer Center

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Leukemia

Leukemia, Lymphoid

Pneumonia

Leukemia, Lymphocytic, Chronic, B-Cell

Pneumonia, Pneumococcal

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Antineoplastic Agents

Molgramostim

Sargramostim

Heptavalent Pneumococcal Conjugate Vaccine

Immunologic Factors

Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.

First vaccine dose subcutaneously, Day 0.

Starting with 3 doses of 250 micrograms subcutaneously, either pre or post vaccine. For pre vaccine, GM-CSF on days -7 (+ 1 day) and -3 (+ 1 day), in the week prior to vaccination for pre-vaccination immune priming; 3rd dose on the day of vaccination (day 0); and for post-vaccine GM-CSF given simultaneously on day of vaccination (day 0) and 2 more doses Day +3 and Day +7 after pneumococcal vaccine.

Sargramostim (GM-CSF)

Pneumococcal Vaccine

Amar Safdar, MD

The goal of this clinical research study is to see if Leukine(R) (sargramostim) improves the effectiveness of the pneumococcal vaccine, a medicine used to prevent pneumococcal pneumonia, in patients with chronic lymphocytic leukemia (CLL).

Sargramostim (also commonly called granulocyte macrophage colony stimulating factor - GM-CSF) is a medication used to stimulate the bone marrow production of white blood cells before a stem cell transplant, after chemotherapy or after a bone marrow transplant. Pneumococcal vaccine is a medication used to prevent infections caused by a bacteria called Streptococcus pneumoniae.

If you have not had a gammaglobulins test (a test to measure immunity against certain infectious diseases) measured within three months before the study begins, then this blood test will be done before you receive any study medications.

Women who are able to have children must have a negative urine pregnancy test before starting treatment.

After consenting to this study, you will be randomly assigned (as in the toss of a coin) to receive treatment with sargramostim in addition to the pneumococcal vaccine or to receive pneumococcal vaccine alone (Prevnar).

* If you are randomized to vaccine plus sargramostim group, you will receive an injection of sargramostim at the same time you receive the pneumococcal vaccine.
* If you are randomized to the vaccine alone group, you will receive the pneumococcal vaccine on the first day.

Blood tests will be performed on the day of the pneumococcal vaccination, and 4 weeks, 12 weeks and 24 weeks after vaccination. Each of the blood tests will require about 4 teaspoons of blood. These blood tests will measure your immunity to pneumococcal infection.

If after 6 months of your first vaccination your body is not able to show immunity to pneumococcal infection, you will receive a second dose either pneumococcal vaccine plus sargramostim or pneumococcal vaccine alone. Your immunity will be checked again at 4 weeks, 12 weeks, and 24 weeks after this second dose. Only 4 teaspoon of blood will be required for the tests.

You may be removed from the study if you have a severe allergic reaction to the sargramostim and/or pneumococcal vaccine. The total maximum time you will be on this is study is 24 months.

This is an investigational study. Both of the medications used in this study are approved by the FDA. Up to 50 patients may be treated on this study. All will be enrolled at M.D. Anderson.

Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients

Immuno-Augmentation With GM-CSF in Patients Receiving Pneumococcal Vaccine While Undergoing Treatment for Advanced Chronic Lymphocytic Leukemia (CLL)

Response defined as 2-fold rise in anticapsular immunoglobulin G (IgG) when prevaccination titer is compared with levels post vaccination and with a final level of \>0.5 ug/mL. Anti-pneumococcal immunoglobulin titers measured at baseline and 1 month after vaccine. Response determined by measuring serum IgG to capsular polysaccharides from 6 of the most common infecting serotypes of Streptococcus pneumoniae.

Bayer

Pneumococcal Vaccine + GM-CSF

Pneumococcal Vaccine Alone

Total

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Amar Safdar, MD/Professor

Pneumococcal Serotype 4

Pneumococcal Serotype 6B

Pneumococcal Serotype 9V

Pneumococcal Serotype 14

Pneumococcal Serotype 19F

Pneumococcal Serotype 23F

Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given pre vaccination Day -7, Day -1 and Day 0 (day of pneumococcal vaccine).

Pneumococcal Vaccine + Pre Vaccine GM-CSF

Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given Day 0 (day of pneumococcal vaccine), and post vaccination at Day +3 and Day +7.

Pneumococcal Vaccine + Post Vaccine GM-CSF

First vaccine dose subcutaneously, Day 0. No CM-CSF.

Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation	NCT06181656	Pneumococcal Va... Esophageal Canc... Lymphopenia Chemoradiation	Pneumonia vacci...	18 Years -	M.D. Anderson Cancer Center
Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients	NCT00323557	Leukemia	Sargramostim (G... Pneumococcal Va...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for pneumococcal vaccine