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

High Grade Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041611
• Other study ID #: J1389
• Secondary ID: NA_00086826
• Status: Completed
• Phase: N/A
• Start date: July 13, 2012
• Est. completion date: December 17, 2015

Study information

• Verified date: June 2018
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 17, 2015
• Est. primary completion date: September 2, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioma
• High Grade Glioma

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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