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

June 26, 2018 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard Care Pts Eval of T-Cell Immune Status
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
Procedure: Blood collections
pts will have 6 blood collections (30ml/collection) throughout course of standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 time points in pts undergoing standard RT/TMZ and adjuvant TMZ

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Washington University School of Medicine

Investigators

  • Study Chair: Stuart A Grossman, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2012

Primary Completion (Actual)

September 2, 2013

Study Completion (Actual)

December 17, 2015

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 17, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J1389
  • NA_00086826 (Other Identifier: JHMIRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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