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.
- 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.
- 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|
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