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

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.

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Key information

Conditions

High Grade Glioma Glioma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins, Baltimore, Maryland, United States

About this study

Numbers of T-cell subtypes at six time points in patients with newly diagnosed HGGs undergoing standard RT/TMZ and adjuvant TMZ:

Baseline within 2 weeks before initiation of RT/TMZ
At the end of RT/TMZ approximately week 6
Before adjuvant TMZ approximately week 10
After 2 cycle of TMZ approximately week 18
After 4 cycle of TMZ approximately week 26
Three month after last cycle of TMZ

Secondary Endpoints

Changes in serial T cell subtypes and cytokines levels
Incidence of lymphopenia related infections
Changes in T-cell numbers and subtypes with TMZ administration
Overall survival

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood collections

Procedure

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

baseline approx 6wks approx 10wks aprox 18wks approx 26wks 3 months after last cycle of TMZ

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

Washington University School of Medicine

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2015
First posted: Jan 22, 2014
Registry last updated: Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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