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

Not Applicable

Completed

• Conditions: High Grade Glioma
• Interventions: Procedure: Blood collections

• Registration Number: NCT02041611
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

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

Numbers of T-cell subtypes at six time points in patients with newly diagnosed HGGs undergoing standard RT/TMZ and adjuvant TMZ:

1. Baseline within 2 weeks before initiation of RT/TMZ

2. At the end of RT/TMZ approximately week 6

3. Before adjuvant TMZ approximately week 10

4. After 2 cycle of TMZ approximately week 18

5. After 4 cycle of TMZ approximately week 26

6. Three month after last cycle of TMZ

Secondary Endpoints

1. Changes in serial T cell subtypes and cytokines levels

2. Incidence of lymphopenia related infections

3. Changes in T-cell numbers and subtypes with TMZ administration

4. Overall survival

Study Timeline

• Study Start: 2012-07-13
• Primary Completion: 2013-09-02
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-22
• Study Completion: 2015-12-17
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients must be at least 18 years of age.
2. Patients must have histologically confirmed new diagnosed high grade glioma by pathology (WHO grade III and IV).
3. Patients proposed post-operative treatment plan must include standard radiation and temozolomide.
4. 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).
5. Patients must be able to provide written informed consent.
6. Steroid use is allowed.

Exclusion Criteria

1. Patients with HIV are excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard Care Pts Eval of T-Cell Immune Status	Blood collections	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

Primary Outcome Measures

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

Trial Locations

Locations (2)

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States