Qualitative, Qualitative, and Functional Studies Over the First Year in Measuring Immune System Response During the First Year of Therapy in Patients With Brain Tumors
NCT ID: NCT02747407
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
55 participants
OBSERVATIONAL
2016-05-31
2021-09-09
Brief Summary
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Detailed Description
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I. To describe the quantity of immune cells underlying the antitumor immune response including dendritic cells, naive and activated T- and B-cells, regulatory T-cells, and natural killer cells.
II. To determine the proliferative ability of lymphocytes via T-cell activation.
SECONDARY OBJECTIVES:
I. To describe the immunologic response to the hepatitis A vaccine (or hepatitis B vaccine in those who are hepatitis A exposed) in comparison to expected/known normal responses either prior to (i.e. pre-treatment) or following chemoradiation (i.e. post-treatment).
II. To describe the immunologic response to tetanus toxoid vaccination compared to expected/known normal responses either prior to (i.e. pre-treatment) or following chemoradiation (i.e. post-treatment).
TERTIARY OBJECTIVES:
I. To describe the immunologic response to the yearly influenza vaccination over the course of the first year of therapy for glioma (timing of administration will be when clinically indicated over this year of therapy).
II. To describe the frequency of viral infection in glioma patients hospitalized during the respiratory viral season within year 1 of therapy.
III. To describe the overall survival of glioma patients enrolled in this study and describe the overall survival in these patients by changes in immunologic function.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive standard of care hepatitis A or B vaccine, tetanus toxoid vaccine, and trivalent influenza vaccine and then undergo standard of care treatment external beam radiation therapy and receive standard of care temozolomide. Patients also undergo collection of blood Samples monthly for the first 8 months and then bimonthly for up to 12 months for analysis via flow cytometry, carboxyfluorescein diacetate succinimidyl ester (CFSE) assay, live cell/dead cell distinction assay, and determination of naïve and memory immune response.
GROUP II: Patients undergo standard of care treatment and collection of blood samples as in Group I. Patients then receive hepatitis A and tetanus toxoid vaccinations at month 9.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Basic Science Group II (vaccination at 9 months)
Patients undergo standard of care treatment and collection of blood samples as in Group I. Patients then receive hepatitis A and tetanus toxoid vaccinations at month 9.
Hepatitis A Vaccine
Laboratory Biomarker Analysis
Correlative studies
Tetanus Toxoid Vaccine
Trivalent Influenza Vaccine
Basic Science Groups I (vaccination pre-treatment)
Patients receive standard of care hepatitis A or B vaccine, tetanus toxoid vaccine, and trivalent influenza vaccine and then undergo standard of care treatment external beam radiation therapy and receive standard of care temozolomide. Patients also undergo collection of blood Samples monthly for the first 8 months and then bimonthly for up to 12 months for analysis via flow cytometry, (CFSE) assay, live cell/dead cell distinction assay, and determination of naïve and memory immune response.
Hepatitis A Vaccine
Laboratory Biomarker Analysis
Correlative studies
Tetanus Toxoid Vaccine
Trivalent Influenza Vaccine
Interventions
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Hepatitis A Vaccine
Laboratory Biomarker Analysis
Correlative studies
Tetanus Toxoid Vaccine
Trivalent Influenza Vaccine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Anticipated to undergo treatment with concurrent chemoradiation with conformal external beam radiotherapy in combination with low-dose temozolomide (75 mg/m\^2) followed by adjuvant temozolomide (150-200 mg/m\^2)
* Able to provide informed consent
* Karnofsky performance status \>= 50%
* Willing and able to receive the tetanus toxoid and hepatitis vaccination (though prior vaccination with either vaccine is not a contraindication to eligibility)
Exclusion Criteria
* Patients unable to receive tetanus toxoid vaccination
* Guillain-Barré syndrome =\< 6 weeks after previous dose of a tetanus toxoid-containing vaccine; unstable neurologic condition (e.g., cerebrovascular events and acute encephalopathic conditions) which does not include the patient's primary brain tumor; history of an Arthus reaction following a previous dose of a tetanus toxoid-containing and/or diphtheria toxoid-containing vaccine
* Patients unable to receive hepatitis vaccination
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Roy Strowd
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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NCI-2016-00472
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU 01316
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00037250
Identifier Type: -
Identifier Source: org_study_id