Glioblastoma Multiforme of BrainPhase 2NCT02137759
MRSI to Predict Response to RT/TMZ ± Belinostat in GBM
A Phase 2 study testing Standard Radiation Therapy, Standard Temozolomide and Belinostat in people with Glioblastoma Multiforme of Brain, run by Emory University at 2 sites in United States.
Trial summary
In the first phase of this study (Cohort 1), the investigators will determine the feasibility of adding MRSI to the evaluation of newly-diagnosed GBM patients treated with standard RT/TMZ and determine whether magnetic resonance spectroscopic imaging (MRSI) can predict for better outcomes in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme of Brain
- What is being tested?
- Standard Radiation Therapy, Standard Temozolomide and Belinostat
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 May 2014to 24 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Newly-diagnosed glioblastoma or gliosarcoma that has been confirmed pathologically
- ≥ 18 years of age
- Able to have MRI scans
- Measurable contrast-enhancing supratentorial tumor (≥ 0.2 cc (current resolution of MRSI is 0.108cc)) in a region amenable to MRSI
- Have the following lab values ≤ 14 days prior to registration:
- white blood cell count ≥ 3,000/μL
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- absolute neutrophil count ≥ 1,500/μL
- platelet count of ≥ 100,000/μL
- hemoglobin ≥ 10 gm/dL (transfusion is allowed to reach minimum level)
- serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.0x upper normal limit (UNL)
- bilirubin ≤ 2 x UNL
- creatinine ≤ 1.5 mg/dL
- Life expectancy of ≥ 12 weeks
- Karnofsky Performance Score ≥ 60
- Women of childbearing potential must have a negative beta-human chorionic gonadotropin pregnancy test documented ≤ 7 days prior to registration
- All men and women of childbearing potential must agree to use adequate barrier contraception for the duration of study participation and for 12 weeks after the last dose of study drug (If pregnancy or suspected pregnancy occur while participating in study, treating physician should be informed immediately)
- Understand and provide written informed consent
- Both men and women, and members of all races and ethnic groups are eligible for this trial (Subjects will be approximately representative of the demographics of the referral base for the participating institutions)
- Able to swallow capsules
- Willing to provide mandatory tissue samples (unstained slides) for research purposes
- Willing to forego other cytotoxic and non-cytotoxic therapies against the tumor while being treated on this protocol
Who cannot join
- Pacemakers, non-titanium aneurysm clips, neurostimulators, cochlear implants, non-titanium metal in ocular structures, history of being a steel worker, or other incompatible implants which makes MRI safety an issue
- Any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
- History of any other invasive cancer (except non-melanoma skin cancer and excluding carcinoma in-situ), unless in complete remission and off of all therapy for that disease for ≥ 3 years, are ineligible
- Active infection or serious intercurrent medical illness
- Any disease that will obscure toxicity or dangerously alter drug metabolism
- Receiving any other investigational agents
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- Received prior cytotoxic, non-cytotoxic or experimental drug therapies for brain tumor
- History of prior cranial radiation
- History of myocardial infarction or unstable angina ≤ 6 months prior to registration or congestive heart failure (CHF) requiring use of ongoing maintenance therapy, or life-threatening ventricular arrhythmias
- Patients with congenital long QT syndrome (for cohorts 2a and 2b [belinostat cohorts] only, ECG not required for cohort 1)
- Has prolonged corrected QT (QTc) interval (> 450 msec) (for cohorts 2a and 2b [belinostat cohorts] only, ECG not required for cohort 1)
- Taking any of the following Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes ≤ 7 days prior to registration (for cohorts 2a and 2b [belinostat cohorts] only)
- Quinidine, procainamide, disopyramide
- Amiodarone, sotalol, ibutilide, dofetilide
- Erythromycin, clarithromycin
- Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
- Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
- Taking valproic acid ≤ 2 weeks prior to initiation of belinostat therapy (for cohorts 2a and 2b [belinostat cohorts] only)
- Residual enhancing tumor that lies completely within 1-2 cm of the inner table of the skull (Please consult study neuroradiologist or study PIs at your site if there is uncertainty regarding this exclusion criteria)
- May not be enrolled on any other therapeutic trial for which they are receiving an anti-tumor therapy. (Note: patients on the standard therapy arm of another GBM trial that otherwise meet eligibility requirements for this trial remain eligible for cohort 1)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
About this study
Official title: Quantitative Magnetic Resonance Spectroscopic Imaging (MRSI) to Predict Early Response to Standard Radiation Therapy (RT)/Temozolomide (TMZ) ± Belinostat Therapy in Newly-Diagnosed Glioblastomas (GBM)
In the first phase of this study (Cohort 1), the investigators will determine the feasibility of adding MRSI to the evaluation of newly-diagnosed GBM patients treated with standard RT/TMZ and determine whether magnetic resonance spectroscopic imaging (MRSI) can predict for better outcomes in these patients. In the second phase of this study (Cohorts 2a and 2b), the investigators will find the maximum tolerated dose of belinostat for treating newly-diagnosed GBM patients with standard RT/TMZ and will determine whether MRSI can aid clinicians in the early determination of response to this new therapy.
Read the detailed description
Patients will be assigned to Cohort 1 (standard RT/TMZ) followed by entry to either Cohort 1 or Cohort 2a (standard RT/TMZ + dose finding for belinostat), followed by assignment to Cohort 2b (standard RT/TMZ + tolerable dose of belinostat).
Patients will undergo MRSI scans before beginning treatment and then at several time points during treatment to look for the early response of their tumor to treatment. Blood and tumor samples will be used to measure the levels of certain markers within the cancer cells. Patients will also be assessed for the side effects they experience. Progression-free and overall survival outcomes will be recorded. Patients will also have assessment of their depressive symptoms, quality-of-life and neurocognitive function at several time points during and after therapy course.
- Conditions
- Glioblastoma Multiforme of Brain
- Being tested
- Standard Radiation Therapy, Standard Temozolomide, Belinostat
- Keywords
- Glioblastoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Radiation TherapyRadiation
Radiation therapy to 60 Gy
Standard TemozolomideDrug
Also called Temodar
Temozolomide given orally
BelinostatDrug
Also called Beleodaq, PXD101
Belinostat dose to be determined, given intravenously over 30-45 minutes
| Study group | Role | What they receive |
|---|---|---|
| Std RT/TMZ (Cohort 1) | Active comparator | * Standard radiation therapy
* Standard temozolomide Receives: Radiation: Standard Radiation Therapy; Drug: Standard Temozolomide |
| Std RT/TMZ + belinostat (Cohorts 2a, 2b) | Experimental | * Standard radiation therapy
* Standard temozolomide
* Belinostat Receives: Radiation: Standard Radiation Therapy; Drug: Standard Temozolomide; Drug: Belinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
The investigators will use a support vector machine approach to determine an MRSI 5-metabolite profile at week 3 in Cohort 1 that is predictive of prolonged PFS at 9 months.
Measured: From date of registration to date of progression or death
Maximum Tolerated Dose of Belinostat (Cohort 2a)
The investigators will determine the maximum tolerated dose of belinostat (up to 1000 mg/day x 5 days q3weeks x 3) used with standard RT/temozolomide for newly diagnosed GBM patients.
Measured: 9 weeks
Secondary outcomes (2)
Median Overall Survival
Overall survival was defined as the time from the date of surgery until death from any cause. Participants who were alive or lost to follow-up were censored at their last known follow-up. Median overall survival was estimated using the Kaplan-Meier method.
Measured: From the date of surgery until death or last known follow-up; median follow-up was 50 months.
Progression Free Survival
The investigators will determine whether changes in MRSI metabolite maps at day 8 (for Cohort 2 only) and week 11 (for Cohort 1 and 2) predict for PFS at 9 months.
Measured: From date of registration to date of progression or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study start7 May 2014
- Primary completion25 Mar 2019
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glioblastoma Multiforme of BrainStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Spectrum Pharmaceuticals, Inc, National Cancer Institute (NCI), National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Hui-Kuo Shu, Emory University
- Investigators
- Hui-Kuo Shu, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137759
- Sponsor's protocol ID
- IRB00065425
- Other IDs
- Winship2434-13, U01CA172027, F30CA206291, R21NS100244, P30CA138292
- Status last verified
- Oct 2026
- First submitted
- 9 May 2014
- Last updated
- 30 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Magnetic Resonance Spectroscopic Imaging (MRSI) to Predict Early Response to Standard Radiation Therapy (RT)/Temozolomide (TMZ) ± Belinostat Therapy in Newly-Diagnosed Glioblastomas (GBM)
- ClinicalTrials.gov ID
- NCT02137759
- Acronym / sponsor ID
- IRB00065425
- Conditions
- Glioblastoma Multiforme of Brain
- Keywords
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Spectrum Pharmaceuticals, Inc, National Cancer Institute (NCI), National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Study start
- 7 May 2014 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Posted 30 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the first phase of this study (Cohort 1), the investigators will determine the feasibility of adding MRSI to the evaluation of newly-diagnosed GBM patients treated with standard RT/TMZ and determine whether magnetic resonance spectroscopic imaging (MRSI) can predict for better outcomes in these patients. In the second phase of this study (Cohorts 2a and 2b), the investigators will find the maximum tolerated dose of belinostat for treating newly-diagnosed GBM patients with standard RT/TMZ and will determine whether MRSI can aid clinicians in the early determination of response to this new therapy.
Detailed description
Patients will be assigned to Cohort 1 (standard RT/TMZ) followed by entry to either Cohort 1 or Cohort 2a (standard RT/TMZ + dose finding for belinostat), followed by assignment to Cohort 2b (standard RT/TMZ + tolerable dose of belinostat).
Patients will undergo MRSI scans before beginning treatment and then at several time points during treatment to look for the early response of their tumor to treatment. Blood and tumor samples will be used to measure the levels of certain markers within the cancer cells. Patients will also be assessed for the side effects they experience. Progression-free and overall survival outcomes will be recorded. Patients will also have assessment of their depressive symptoms, quality-of-life and neurocognitive function at several time points during and after therapy course.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Std RT/TMZ (Cohort 1) | Active comparator | Radiation: Standard Radiation Therapy, Drug: Standard Temozolomide* Standard radiation therapy * Standard temozolomide |
| Std RT/TMZ + belinostat (Cohorts 2a, 2b) | Experimental | Radiation: Standard Radiation Therapy, Drug: Standard Temozolomide, Drug: Belinostat* Standard radiation therapy * Standard temozolomide * Belinostat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Newly-diagnosed glioblastoma or gliosarcoma that has been confirmed pathologically
- ≥ 18 years of age
- Able to have MRI scans
- Measurable contrast-enhancing supratentorial tumor (≥ 0.2 cc (current resolution of MRSI is 0.108cc)) in a region amenable to MRSI
- Have the following lab values ≤ 14 days prior to registration:
Key exclusion criteria (20 listed)
- Pacemakers, non-titanium aneurysm clips, neurostimulators, cochlear implants, non-titanium metal in ocular structures, history of being a steel worker, or other incompatible implants which makes MRI safety an issue
- Any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
- History of any other invasive cancer (except non-melanoma skin cancer and excluding carcinoma in-situ), unless in complete remission and off of all therapy for that disease for ≥ 3 years, are ineligible
- Active infection or serious intercurrent medical illness
- Any disease that will obscure toxicity or dangerously alter drug metabolism
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 |
|---|---|---|
| Standard Radiation TherapyRadiation therapy to 60 Gy | Radiation | Std RT/TMZ (Cohort 1), Std RT/TMZ + belinostat (Cohorts 2a, 2b) |
| Standard TemozolomideAlso: TemodarTemozolomide given orally | Drug | Std RT/TMZ (Cohort 1), Std RT/TMZ + belinostat (Cohorts 2a, 2b) |
| BelinostatAlso: Beleodaq, PXD101Belinostat dose to be determined, given intravenously over 30-45 minutes | Drug | Std RT/TMZ + belinostat (Cohorts 2a, 2b) |
Primary outcome
Progression Free Survival (PFS)
Time frame: From date of registration to date of progression or death
The investigators will use a support vector machine approach to determine an MRSI 5-metabolite profile at week 3 in Cohort 1 that is predictive of prolonged PFS at 9 months.
Maximum Tolerated Dose of Belinostat (Cohort 2a)
Time frame: 9 weeks
The investigators will determine the maximum tolerated dose of belinostat (up to 1000 mg/day x 5 days q3weeks x 3) used with standard RT/temozolomide for newly diagnosed GBM patients.
2 secondary outcomes
Median Overall Survival
Time frame: From the date of surgery until death or last known follow-up; median follow-up was 50 months.
Progression Free Survival
Time frame: From date of registration to date of progression or death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Hui-Kuo Shu, MD, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard Radiation Therapy, Standard Temozolomide and Belinostat in people with Glioblastoma Multiforme of Brain, run by Emory University 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 21 inclusion and 20 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 30 Oct 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (PFS) (time frame: From date of registration to date of progression or death). The study lists 2 primary outcomes in all. 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 30 Oct 2026.