Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02041611

Enrollment

Registered

2014-01-22

Start date

2012-07-13

Completion date

2015-12-17

Last updated

2018-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Grade Glioma

Keywords

WHO grade III and IV

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

Interventions

PROCEDUREBlood collections

pts will have 6 blood collections (30ml/collection) throughout course of standard treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Changes in T Cell subtypes and cytokines as a function of treatment	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026