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

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.

Inclusion Criteria:

- Clinically or histologically diagnosed primary central nervous system astrocytoma or
oligodendroglioma of World Health Organization grade II, III or IV

- 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:

- Concurrent enrollment on an experimental study involving an agent whose primary
mechanism of action is the immune system (i.e. immune checkpoint inhibition, oncologic
vaccine, or other immune-directed therapies); Note: patients enrolled on an
experimental study or receiving another concurrent treatment in addition to standard
chemoradiation whose primary mechanism of action is NOT the immune system will be
eligible for enrollment

- 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