Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- High Grade Glioma
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Changes in T Cell subtypes and cytokines as a function of treatment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients with HIV are excluded.
Outcomes
Primary Outcomes
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
baseline approx 6wks approx 10wks aprox 18wks approx 26wks 3 months after last cycle of TMZ