Spots Global Cancer Trial Database for Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas
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Trial Identification
Brief Title: Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas
Official Title: Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas
Study ID: NCT02041611
Conditions
Interventions
Study Description
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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Johns Hopkins, Baltimore, Maryland, United States
Washington University, Saint Louis, Missouri, United States
Contact Details
Name: Stuart A Grossman, MD
Affiliation: Johns Hopkins University
Role: STUDY_CHAIR
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