NCT02747407

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

Determining the Competence of the Immune System Over the First Year of Therapy in Patients With Glioma: A Battery of Quantitative, Qualitative and Functional Measures of Immune Readiness

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research trial studies qualitative, qualitative, and functional studies over the first year in measuring immune system response in patients with brain tumors. Measuring the number of immune cells, whether these immune cells work correctly, and response to 2 vaccines at several times during the first year of treatment may help find out how active the immune system responds to fight infection and cancer.

Detailed description

PRIMARY OBJECTIVES: 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

• Astrocytoma
• Glioma
• Oligodendroglioma

Interventions

Type	Name	Description
BIOLOGICAL	Hepatitis A Vaccine
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Tetanus Toxoid Vaccine
BIOLOGICAL	Trivalent Influenza Vaccine

Timeline

• Start date: 2016-05-01
• Primary completion: 2020-01-01
• Completion: 2021-09-09
• First posted: 2016-04-21
• Last updated: 2021-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study