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

NCT02747407 | Completed DMC FDA Drug

• 4 other identifiers: IRB00037250NCI-2016-00472CCCWFU 01316P30CA012197
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Astrocytoma; Glioma; Oligodendroglioma

Outcome Measures

Primary Outcomes (2)

• Proliferative ability of lymphocytes by carboxyfluorescein diacetate succinimidyl ester assay

  Mean values of the quantitative measures and proliferative ability will be calculated for each four time points and compared to determine the trajectory over time as described. In addition, the repeated measures for quantitative measures will be displayed graphically with individual trajectories. The linear mixed model will be performed to identify predictors (e.g., sex) that are associated with the quantitative measures. Furthermore, the generalized estimating equations model with the logit link and binomial distribution will be used to identify predictors for qualitative measures (e.g., prol

  Up to 1 year

• The quantity of cells determined by flow cytometry

  Mean values of the quantitative measures and proliferative ability will be calculated for each four time points and compared to determine the trajectory over time as described. In addition, the repeated measures for quantitative measures will be displayed graphically with individual trajectories. The linear mixed model will be performed to identify predictors (e.g., sex) that are associated with the quantitative measures. Furthermore, the generalized estimating equations model with the logit link and binomial distribution will be used to identify predictors for qualitative measures (e.g., prol

  Up to 1 year

Secondary Outcomes (2)

• Response of the tetanus toxoid vaccine-specific IgG antibody

  At 28 days following tetanus toxoid vaccination

• Vaccine-specific total antibody response after hepatitis A vaccination. In hepatitis A exposed patients, hepatitis B will be used.

  At 28 days post hepatitis A vaccination

Other Outcomes (3)

• Frequency of viral infection

  Up to 1 year

• Overall survival (OS)

  Date of surgery to death from any cause, assessed up to 14 months

• Titer of the influenza vaccine-specific IgG antibody

  At 28 days following vaccination with the trivalent inactivated influenza vaccine

Study Arms (2)

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.

Biological: Hepatitis A Vaccine; Other: Laboratory Biomarker Analysis; Biological: Tetanus Toxoid Vaccine; Biological: 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.

Biological: Hepatitis A Vaccine; Other: Laboratory Biomarker Analysis; Biological: Tetanus Toxoid Vaccine; Biological: Trivalent Influenza Vaccine

Interventions

Hepatitis A Vaccine BIOLOGICAL

Also known as: Havrix, Hepatitis A Vaccine, Inactivated, Vaqta

Basic Science Group II (vaccination at 9 months); Basic Science Groups I (vaccination pre-treatment)

Laboratory Biomarker Analysis OTHER

Correlative studies

Basic Science Group II (vaccination at 9 months); Basic Science Groups I (vaccination pre-treatment)

Tetanus Toxoid Vaccine BIOLOGICAL

Also known as: Tetanus Toxoid, TT

Basic Science Group II (vaccination at 9 months); Basic Science Groups I (vaccination pre-treatment)

Trivalent Influenza Vaccine BIOLOGICAL

Also known as: Agriflu, Flu prevention, Flu prophylaxis, Flu shot, Flu vaccination, Fluarix, Flublok, FluLaval, Flushield, Fluvirin, Fluzone, Influenza Vaccine, Influenza Virus Vaccine, Trivalent, Types A and B, TIV

Basic Science Group II (vaccination at 9 months); Basic Science Groups I (vaccination pre-treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with primary central nervous system astrocytoma or oligodendroglioma

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

Astrocytoma; Glioma; Oligodendroglioma

Interventions

Hepatitis A Vaccines; Tetanus Toxoid; Influenza Vaccines; fluarix; FluBlok; FluLaval

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Toxoids

Study Officials

• Roy Strowd

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 21, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: September 9, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (1)