Glioma Clinical Trial
Official title:
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
Verified date | October 2021 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | September 9, 2021 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Frequency of viral infection | The distribution will be plotted using a histogram. Assessment of influenza vaccine immunogenicity will be performed. GMTs will be calculated at baseline and day 28. Seroconversion (i.e. 4-fold rise in GMT from baseline to day 28) will be determined. Proportions will be binned according to the timing of influenza vaccination: (1) pre-treatment, (2) during radiation, (3) during adjuvant chemotherapy, and (4) post-treatment. Seroconversion proportion within each time point will be compared against known normal using a one proportion test. | Up to 1 year | |
Other | Overall survival (OS) | The Kaplan Meier method will be used to estimate OS probability and median time of survival along with 95% confidence interval. Proportional hazards models will be used to assess for associations between mortality and baseline quantitative immunologic values, baseline qualitative immunologic function, and baseline and post-treatment seroconversion to each vaccine (treated as a time dependent variable). All p-values will be reported as two-sided. | Date of surgery to death from any cause, assessed up to 14 months | |
Other | Titer of the influenza vaccine-specific IgG antibody | Baseline and day 28 geometric mean titers (GMTs) will be calculated for hepatitis A or B and tetanus. GMTs for patients undergoing vaccination pre- and post-treatment will be performed. The difference in 28 day GMT between pretreatment and posttreatment will be compared using the paired t test. Analysis of covariance will be used to identify predictors that are associated with the change of 28 day difference in GMT. Seroconversion or a 4-fold rise in GMT from baseline to day 28 will be determined for pre and post treatment patient cohorts. Seroconversion proportion will be compared against kno | At 28 days following vaccination with the trivalent inactivated influenza vaccine | |
Primary | 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 | |
Primary | 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 | Response of the tetanus toxoid vaccine-specific IgG antibody | Baseline and day 28 geometric mean titers (GMTs) will be calculated for hepatitis A or B and tetanus. GMTs for patients undergoing vaccination pre- and post-treatment will be performed. The difference in 28 day GMT between pretreatment and posttreatment will be compared using the paired t test. Analysis of covariance will be used to identify predictors that are associated with the change of 28 day difference in GMT. Seroconversion or a 4-fold rise in GMT from baseline to day 28 will be determined for pre and post treatment patient cohorts. Seroconversion proportion will be compared against kno | At 28 days following tetanus toxoid vaccination | |
Secondary | Vaccine-specific total antibody response after hepatitis A vaccination. In hepatitis A exposed patients, hepatitis B will be used. | Baseline and day 28 geometric mean titers (GMTs) will be calculated for each vaccine (i.e. hepatitis A or B and tetanus). GMTs for patients undergoing vaccination pre- and post-treatment will be performed. The difference in 28-day GMT between pre-treatment and post-treatment will be compared using the paired-t test. Analysis of covariance will be used to identify predictors that are associated with the change of 28-day difference in GMT. Seroconversion or a 4-fold rise in GMT from baseline to day-28 will be determined for pre- and post-treatment patient cohorts. Seroconversion proportion will | At 28 days post hepatitis A vaccination |
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