This trial is active, not recruiting.

Condition high grade glioma
Treatment blood collections
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking open label
Pts undergoing standard radiation/TMZ and adjuvant TMZ will have blood collections at 6 different time points throughtout their treatment to evaluate T Cell changes
blood collections
pts will have 6 blood collections (30ml/collection) throughout course of standard treatment

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

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.