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Histone Deacetylase Inhibitor

MRSI + RT/TMZ ± Belinostat for GBM

Phase 2
Waitlist Available
Led By Hui-Kuo Shu, MD, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable contrast-enhancing supratentorial tumor (≥ 0.2 cc (current resolution of MRSI is 0.108cc)) in a region amenable to MRSI
Newly-diagnosed glioblastoma or gliosarcoma that has been confirmed pathologically
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing whether adding MRSI to the standard evaluation for newly diagnosed GBM patients treated with RT/TMZ can help predict better outcomes, and whether MRSI can aid in the early determination of response to this new therapy.

Who is the study for?
This trial is for adults over 18 with newly-diagnosed glioblastoma or gliosarcoma confirmed by pathology, who can have MRI scans and meet specific blood lab value criteria. They must not have incompatible implants for MRI, other invasive cancers (except certain types), serious illnesses affecting the study participation, prior brain tumor treatments, or be on any investigational agents.Check my eligibility
What is being tested?
The study tests if adding MRSI to standard RT/TMZ treatment helps predict outcomes in GBM patients. It also seeks the safest dose of belinostat combined with RT/TMZ and checks if MRSI can early determine response to this new therapy.See study design
What are the potential side effects?
Potential side effects include those associated with radiation therapy and chemotherapy such as fatigue, nausea, hair loss, skin changes at the irradiated area; plus any additional risks from belinostat which may include gastrointestinal issues and changes in blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor is visible on scans and can be measured.
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I have been newly diagnosed with glioblastoma or gliosarcoma.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose of Belinostat (Cohort 2a)
Progression Free Survival (PFS) (Cohort 1)
Progression Free Survival (PFS) (Cohort 2b)
Secondary outcome measures
IDS-SR score change
Overall Survival
Progression Free Survival
Other outcome measures
Impaired cognition
QOL changes

Side effects data

From 2012 Phase 2 trial • 32 Patients • NCT00301756
88%
Fatigue
81%
Nausea
75%
Lymphocyte count decreased
72%
Constipation
3%
Abdominal pain
3%
Urinary tract infection
3%
Lower gastrointestinal hemorrhage
3%
Dyspnea
3%
Pleural infection
3%
Upper gastrointestinal hemorrhage
3%
Activated partial thromboplastin time prolonged
3%
Dehydration
3%
Pneumonitis
3%
Cytokine release syndrome
3%
Small intestinal obstruction
3%
Arthralgia
3%
Non-cardiac chest pain
3%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Enzyme Inhibitor Therapy)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Std RT/TMZ + belinostat (Cohorts 2a, 2b)Experimental Treatment3 Interventions
Standard radiation therapy Standard temozolomide Belinostat
Group II: Std RT/TMZ (Cohort 1)Active Control2 Interventions
Standard radiation therapy Standard temozolomide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belinostat
FDA approved
Standard Radiation Therapy
2012
N/A
~10

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityOTHER
2,259 Previous Clinical Trials
14,820,624 Total Patients Enrolled
2 Trials studying Glioblastoma
54 Patients Enrolled for Glioblastoma
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,544 Total Patients Enrolled
11 Trials studying Glioblastoma
319 Patients Enrolled for Glioblastoma
Spectrum Pharmaceuticals, IncIndustry Sponsor
82 Previous Clinical Trials
8,160 Total Patients Enrolled
1 Trials studying Glioblastoma
18 Patients Enrolled for Glioblastoma

Media Library

Belinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02137759 — Phase 2
Glioblastoma Research Study Groups: Std RT/TMZ (Cohort 1), Std RT/TMZ + belinostat (Cohorts 2a, 2b)
Glioblastoma Clinical Trial 2023: Belinostat Highlights & Side Effects. Trial Name: NCT02137759 — Phase 2
Belinostat (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02137759 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
MRSI to Predict Response to RT/TMZ ± Belinostat in GBM
Hui-Kuo Shu 2014. "MRSI to Predict Response to RT/TMZ ± Belinostat in GBM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02137759.
All > Gbm
~3 spots leftby Apr 2025
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