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

Primary Purpose

High Grade Glioma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood collections
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for High Grade Glioma focused on measuring WHO grade III and IV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Johns Hopkins
  • Washington University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Standard Care Pts Eval of T-Cell Immune Status

Arm Description

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

Outcomes

Primary Outcome Measures

Changes in T Cell subtypes and cytokines as a function of treatment
baseline approx 6wks approx 10wks aprox 18wks approx 26wks 3 months after last cycle of TMZ

Secondary Outcome Measures

Full Information

First Posted
January 10, 2014
Last Updated
June 26, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02041611
Brief Title
Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas
Official Title
Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 13, 2012 (Actual)
Primary Completion Date
September 2, 2013 (Actual)
Study Completion Date
December 17, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Grade Glioma
Keywords
WHO grade III and IV

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care Pts Eval of T-Cell Immune Status
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Blood collections
Intervention Description
pts will have 6 blood collections (30ml/collection) throughout course of standard treatment
Primary Outcome Measure Information:
Title
Changes in T Cell subtypes and cytokines as a function of treatment
Description
baseline approx 6wks approx 10wks aprox 18wks approx 26wks 3 months after last cycle of TMZ
Time Frame
6 time points in pts undergoing standard RT/TMZ and adjuvant TMZ

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 1. Patients with HIV are excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart A Grossman, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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