Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas

Study Overview
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Brief Summary
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The primary goal of this study is evaluate T cell immune status and immune reconstitution and the association with specific cytokines in patients with newly diagnosed HGGs undergoing the standard RT/TMZ and adjuvant TMZ.

Detailed Description
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Numbers of T-cell subtypes at six time points in patients with newly diagnosed HGGs undergoing standard RT/TMZ and adjuvant TMZ: Baseline within 2 weeks before initiation of RT/TMZ At the end of RT/TMZ approximately week 6 Before adjuvant TMZ approximately week 10 After 2 cycle of TMZ approximately week 18 After 4 cycle of TMZ approximately week 26 Three month after last cycle of TMZ Secondary Endpoints Changes in serial T cell subtypes and cytokines levels Incidence of lymphopenia related infections Changes in T-cell numbers and subtypes with TMZ administration Overall survival

Official Title
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Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas

Conditions
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High Grade Glioma

Intervention / Treatment
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* Procedure: Blood collections


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be at least 18 years of age. Patients must have histologically confirmed new diagnosed high grade glioma by pathology (WHO grade III and IV). Patients proposed post-operative treatment plan must include standard radiation and temozolomide. Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others). Patients must be able to provide written informed consent. Steroid use is allowed. Exclusion Criteria: 1. Patients with HIV are excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Care Pts Eval of T-Cell Immune Status<br>Pts undergoing standard radiation/TMZ and adjuvant TMZ will have blood collections at 6 different time points throughtout their treatment to evaluate T Cell changes | Procedure: Blood collections<br>* pts will have 6 blood collections (30ml/collection) throughout course of standard treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in T Cell subtypes and cytokines as a function of treatment | baseline approx 6wks approx 10wks aprox 18wks approx 26wks 3 months after last cycle of TMZ | 6 time points in pts undergoing standard RT/TMZ and adjuvant TMZ | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WHO grade III and IV