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

Johns Hopkins Medicine

Status: Completed

Conditions: High Grade Glioma

Treatments: Procedure: Blood collections

Study type: Interventional

Funder types: Other

Identifiers

NCT02041611

NA_00086826 (Other Identifier)

J1389

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Standard Care Pts Eval of T-Cell Immune Status

Other group

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

Treatment:

Procedure: Blood collections