Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas
This trial is active, not recruiting.
|Condition||high grade glioma|
|Sponsor||Sidney Kimmel Comprehensive Cancer Center|
|Collaborator||Washington University School of Medicine|
|Start date||January 2014|
|End date||July 2015|
|Trial size||20 participants|
|Trial identifier||NCT02041611, J1389, NA_00086826|
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.
|Endpoint classification||pharmacodynamics study|
|Intervention model||single group assignment|
Changes in T Cell subtypes and cytokines as a function of treatment
time frame: 6 time points in pts undergoing standard RT/TMZ and adjuvant TMZ
Male or female participants at least 18 years old.
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.
|Official title||Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas|
|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|
Call for more information