Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02137759
Other study ID # IRB00065425
Secondary ID Winship2434-13U0
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date May 7, 2014
Est. completion date August 15, 2024

Study information

Verified date May 2023
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Standard Radiation Therapy
Radiation therapy to 60 Gy
Drug:
Standard Temozolomide
Temozolomide given orally
Belinostat
Belinostat dose to be determined, given intravenously over 30-45 minutes

Locations

Country Name City State
United States Emory University/Winship Cancer Institute Atlanta Georgia
United States Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland

Sponsors (6)

Lead Sponsor Collaborator
Emory University Johns Hopkins University, National Cancer Institute (NCI), National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Spectrum Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other QOL changes The investigators will determine whether changes in MRSI metabolite maps correlate with changes in subjects' quality-of-life (QOL) as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (QLQ-C30/BN20) and the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT), validated instruments for assessing QOL in brain tumor patients. up to 2 years
Other Neurocognitive function changes The investigators will determine whether changes in MRSI metabolite maps correlate with changes in subjects' neurocognitive function as measured by the Hopkins Verbal Learning Test-Revised (HVLT-R), the Controlled Oral Word Association (COWA) Test and the Trail Making Test (TMT) Parts A & B, validated instruments for evaluating neurocognitive function in brain tumor patients. up to 2 years
Primary Progression Free Survival (PFS) (Cohort 1) 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. 9 months
Primary 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. 9 weeks
Primary Progression Free Survival (PFS) (Cohort 2b) The investigators will determine if MRSI biomarkers at week 3 in GBM patients from Cohort 2b can distinguish belinostat responders from non-responders and predict improved PFS at 9 months. 9 months
Secondary Overall Survival The investigators will determine whether changes in MRSI metabolite maps at day 8 (for Cohort 2 only), week 3 (for Cohort 1 and 2) and week 11 (for Cohort 1 and 2) predict for overall survival at 18 months. 18 months
Secondary 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. 9 months
Secondary IDS-SR score change The investigators will determine whether changes in the MRSI metabolite map at week 11 predict for mood alterations as measure by the Inventory of Depressive Symptomatology-Self Report (IDS-SR), a validated instrument for depression assessment, in Cohorts 1 and 2. 11 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT03657576 - Trial of C134 in Patients With Recurrent GBM Phase 1
Recruiting NCT05685004 - Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM) Phase 2/Phase 3
Recruiting NCT05076513 - Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma Early Phase 1
Active, not recruiting NCT03665545 - Pembrolizumab in Association With the IMA950/Poly-ICLC for Relapsing Glioblastoma Phase 1/Phase 2
Completed NCT02474966 - Effect of Deep TMS on the Permeability of the BBB in Patients With Glioblastoma Multiforme: a Pilot Study Phase 2
Enrolling by invitation NCT03170141 - Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme Phase 1
Recruiting NCT04842513 - Multi Peptide Vaccination With XS15 in Addition to Standard Postoperative Radiation Therapy and Temozolomide Chemotherapy in Newly Diagnosed Glioblastoma Phase 1
Recruiting NCT04869449 - Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas Early Phase 1
Recruiting NCT03633552 - Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma Phase 3
Not yet recruiting NCT05095441 - A Clinical Study of Intratumoral MVR-C5252 (C5252) in Patients With Recurrent or Progressive Glioblastoma Phase 1
Completed NCT00003456 - Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme Phase 2
Completed NCT03047473 - Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme Phase 2
Enrolling by invitation NCT05116137 - The Impact of Resistance ExerciSe on Muscle Mass in GlioblaSToma Survivors N/A
Recruiting NCT05627323 - CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma Phase 1
Active, not recruiting NCT04968366 - Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery Phase 1
Suspended NCT04222309 - Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM) Phase 1
Not yet recruiting NCT06186440 - Cisplatin Plus Temozolomide Compared With Temozolomide in Patients With MGMT Promotor Unmethylated Glioblastoma Phase 1/Phase 2
Recruiting NCT06283927 - The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
Recruiting NCT06146725 - The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
Recruiting NCT06273176 - The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma