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

NCT02041611 | Completed DMC

• 2 other identifiers: J1389NA_00086826
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

High Grade Glioma

Keywords

WHO grade III and IV

Outcome Measures

Primary Outcomes (1)

• 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

  6 time points in pts undergoing standard RT/TMZ and adjuvant TMZ

Study Arms (1)

Standard Care Pts Eval of T-Cell Immune Status

OTHER

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

Interventions

Blood collections PROCEDURE

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

Standard Care Pts Eval of T-Cell Immune Status

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Patients with HIV are excluded.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Washington University School of Medicine: collaborator

Study Sites (2)

Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Glioma; Lymphoma, Follicular

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Stuart A Grossman, MD

  Johns Hopkins University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 22, 2014
• Study Start: July 13, 2012
• Primary Completion: September 2, 2013
• Study Completion: December 17, 2015
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

US (2)