High Grade GliomaNCT02041611
Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas
A study testing Blood collections in people with High Grade Glioma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Glioma
- What is being tested?
- Blood collections
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jul 2012to 17 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Patients with HIV are excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins
Baltimore, Maryland, 21231
Washington University
St Louis, Missouri, 63110
About this study
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.
Read the 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
- Conditions
- High Grade Glioma
- Being tested
- Blood collections
- Keywords
- WHO grade III and IV
- Medical subject headings
- Glioma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionsProcedure or surgery
pts will have 6 blood collections (30ml/collection) throughout course of standard treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Blood collections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 time points in pts undergoing standard RT/TMZ and adjuvant TMZ
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study start13 Jul 2012
- Primary completion2 Sep 2013
- Study completion17 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Stuart A Grossman, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041611
- Sponsor's protocol ID
- J1389
- Other IDs
- NA_00086826
- Status last verified
- Jun 2018
- First submitted
- 10 Jan 2014
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas
- ClinicalTrials.gov ID
- NCT02041611
- Acronym / sponsor ID
- J1389
- Conditions
- High Grade Glioma
- Keywords
- WHO grade III and IV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- 13 Jul 2012 (actual)
- Primary completion
- 2 Sep 2013 (actual)
- Study completion
- 17 Dec 2015 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard Care Pts Eval of T-Cell Immune Status | Other | Procedure: Blood collectionsPts undergoing standard radiation/TMZ and adjuvant TMZ will have blood collections at 6 different time points throughtout their treatment to evaluate T Cell changes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Patients with HIV are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionspts will have 6 blood collections (30ml/collection) throughout course of standard treatment | Procedure or surgery | Standard Care Pts Eval of T-Cell Immune Status |
Primary outcome
Changes in T Cell subtypes and cytokines as a function of treatment
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart A Grossman, MD study chair
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collections in people with High Grade Glioma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in T Cell subtypes and cytokines as a function of treatment (time frame: 6 time points in pts undergoing standard RT/TMZ and adjuvant TMZ). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.