NCT02137759

MRSI to Predict Response to RT/TMZ ± Belinostat in GBM

Status unknown Phase 2 Last updated 6 May 2023

What this trial tests

Phase 2 trial testing Standard Radiation Therapy in Glioblastoma Multiforme of Brain in 29 participants. Status unknown.

Timeline

7 May 2014

Primary endpoint
15 August 2023

15 August 2024

Quick facts

Lead sponsor	Emory University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	7 May 2014
Primary completion	15 August 2023
Estimated completion	15 August 2024
Sites	2 locations across United States

Drugs / interventions tested

• Standard Radiation Therapy
• Standard Temozolomide — full drug profile →
• Belinostat (belinostat) — full drug profile →

Conditions studied

• Glioblastoma Multiforme of Brain — all drugs for Glioblastoma Multiforme of Brain →

Sponsor

Emory University

Who can join

18 and older, any sex, with Glioblastoma Multiforme of Brain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Challenges and Opportunities in Treating Glioblastoma.
   Shergalis A, Bankhead A, Luesakul U, Muangsin N, et al · · 2018 · cited 612× · PMID 29669750 · DOI 10.1124/pr.117.014944
2. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
3. Synergistic Enhancement of Cancer Therapy Using HDAC Inhibitors: Opportunity for Clinical Trials.
   Hontecillas-Prieto L, Flores-Campos R, Silver A, de Álava E, et al · · 2020 · cited 145× · PMID 33024443 · DOI 10.3389/fgene.2020.578011
4. The application of histone deacetylases inhibitors in glioblastoma.
   Chen R, Zhang M, Zhou Y, Guo W, et al · · 2020 · cited 93× · PMID 32682428 · DOI 10.1186/s13046-020-01643-6
5. Advances in epigenetic glioblastoma therapy.
   Lee DH, Ryu HW, Won HR, Kwon SH. · · 2017 · cited 74× · PMID 28099914 · DOI 10.18632/oncotarget.14612
6. Intertumoral heterogeneity in patient-specific drug sensitivities in treatment-naïve glioblastoma.
   Skaga E, Kulesskiy E, Fayzullin A, Sandberg CJ, et al · · 2019 · cited 52× · PMID 31238897 · DOI 10.1186/s12885-019-5861-4
7. Epigenetic drugs in cancer therapy.
   Suraweera A, O'Byrne KJ, Richard DJ. · · 2025 · cited 50× · PMID 40011240 · DOI 10.1007/s10555-025-10253-7
8. The Use of Quantitative Imaging in Radiation Oncology: A Quantitative Imaging Network (QIN) Perspective.
   Press RH, Shu HG, Shim H, Mountz JM, et al · · 2018 · cited 38× · PMID 29966725 · DOI 10.1016/j.ijrobp.2018.06.023