NCT02041611

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• High Grade Glioma

Interventions

Type	Name	Description
PROCEDURE	Blood collections	pts will have 6 blood collections (30ml/collection) throughout course of standard treatment

Timeline

• Start date: 2012-07-13
• Primary completion: 2013-09-02
• Completion: 2015-12-17
• First posted: 2014-01-22
• Last updated: 2018-06-27

Locations

2 sites across 1 country: United States