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

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Completed
• CT.gov ID: NCT02041611
• Collaborator: Washington University School of Medicine (Other)
• Enrollment: 20
• Locations: 2
• Arm: 1
• Actual Duration (Months): 41.1
• Patients Per Site: 10
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
High Grade Glioma	Procedure: Blood collections	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas
• Actual Study Start Date: Jul 13, 2012
• Actual Primary Completion Date: Sep 2, 2013
• Actual Study Completion Date: Dec 17, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in T Cell subtypes and cytokines as a function of treatment [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins	Baltimore	Maryland	United States	21231
2	Washington University	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT02041611
• Other Study ID Numbers: J1389; NA_00086826
• First Posted: Jan 22, 2014
• Last Update Posted: Jun 27, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: WHO grade III and IV
• Additional relevant MeSH terms: Glioma

Study Results

No Results Posted as of Jun 27, 2018