Clinical trial · Interventional
Magnetic Resonance Spectroscopy Imaging in Predicting Response to Vorinostat and Temozolomide in Patients With Recurrent or Progressive Glioblastoma
Using Proton Magnetic Resonance Spectroscopy (MRS) to Predict Response of Vorinostat Treatment in Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial is studying magnetic resonance spectroscopy imaging in predicting response in patients to vorinostat and temozolomide in patients with recurrent, progressive, or newly diagnosed glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help temozolomide work better by making tumor cells more sensitive to the drug. Imaging procedures, such as magnetic resonance spectroscopy imaging, may help measure the patient's response to vorinostat and temozolomide and allow doctors to plan better treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Glioblastoma | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Depression | — | UNRESOLVED | — |
| Recurrent Adult Brain Tumor | Adult Brain Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| magnetic resonance spectroscopic imaging | Procedure | — | UNRESOLVED |
| survey administration | Other | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive vorinostat once daily on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance spectroscopic imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo a survey administration of Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study.
- interventionNames
- Drug: vorinostat
- Drug: temozolomide
- Procedure: magnetic resonance spectroscopic imaging
- Other: survey administration
Primary outcomes (3)
- measure
- Proportion of Patients With Magnetic Resonance Spectroscopy (MRS) Response to Initial Vorinostat by MRI and MRS Scans as Determined by Spectroscopic Index
- timeFrame
- 9 weeks
- description
- Changes in magnetic resonance spectroscopic imaging signal and semiquantitative analysis of inositol, choline, lactate, and N-acetylaspartate signal are measured. The values for each of these metabolites are normalized to baseline at one and nine weeks. The values of all the metabolites at one week are added and this is the magnetic resonance spectroscopic index for one week. This is done again at nine weeks. The number is unitless and there is no range limit. Positive values represent normalization of tumor metabolism and negative values suggest no improvement or worsening of metabolic character.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients must have 1 of the following:
* Diagnosis of recurrent or progressive glioblastoma
* Patients with recurrent disease may have had treatment for any number of prior relapses
* Newly diagnosed glioblastoma and have completed radiation therapy and are receiving standard follow-up temozolomide
* Must be able to have an MRI, and have a measurable contrast-enhancing supratentorial tumor of at least 1 cm by shortest diameter
* Residual disease following resection measuring 1 cm in diameter or greater is mandated for eligibility into the study
* Patients must have a stable or progressive disease as determined by serial brain MRI using the McDonald Criteria on a scan 14 days or fewer before registration and on a stable steroid dose for 5 days
* Patients with prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based upon either positron emission tomography (PET) or thallium scanning, MR spectroscopy, or surgical documentation of disease
* White Blood Cell Count \> 3,000/μL
* Absolute Neutrophil Count \> 1,500/μL
* Platelet count \> 100,000/μL
* Hemoglobin \> 10 g/dL (transfusion allowed)
* Serum glutamate oxaloacetate transaminase \< 2 times upper limit of normal (ULN)
* Bilirubin \< 2 times ULN
* Creatinine \< 1.5 mg/dL
* Negative pregnancy test
* Women of childbearing potential and men must agree to use adequate barrier contraception for the duration of study participation
* Able to swallow capsules
* No patients with pacemakers, non-titanium aneurysm clips, neurostimulators, cochlear implants, non-titanium metal in ocular structures, history of being a steel worker, or other incompatible implants
* No 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
* No history of any other cancer except non-melanoma skin cancer or carcinoma in-situ of the cervix, or cancer in complete remission and off all therapy for ≥ 3 years
* No active infection or serious intercurrent medical illness
* No disease that would obscure toxicity or dangerously alter drug metabolism
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat (SAHA) or other agents used in this study
* No prolonged corrected QT interval waves on baseline EKG
* No other anticancer therapy (including chemotherapy, radiation, hormonal treatment, or immunotherapy) of any kind is permitted during the study period
* At least 3 weeks since prior radiotherapy
* Patients must have recovered from the toxic effects of prior therapy, including surgery
* At least 28 days since any prior investigational agent or prior cytotoxic therapy
* At least 23 days since prior temozolomide
* At least 14 days since prior vincristine (42 days for nitrosourea)
* At least 21 days since prior procarbazine
* At least 7 days since prior non-cytotoxic agents (e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc.)
* At least 2 weeks since prior valproic acid (or another histone deacetylase inhibitor)
* No other concurrent investigational agents
Exclusion Criteria:
* Diagnostic and Statistical Manual-IV Axis I or II diagnosis (as determined by PI), exclusive of nicotine dependence.
* Pregnant.
* Contraindications to MRI: pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
* Active medical or neurological disorder.
* History of alcohol or drug dependenceReferences
Publications (1)
- RESULTShim H, Wei L, Holder CA, Guo Y, Hu XP, Miller AH, Olson JJ. Use of high-resolution volumetric MR spectroscopic imaging in assessing treatment response of glioblastoma to an HDAC inhibitor. AJR Am J Roentgenol. 2014 Aug;203(2):W158-65. doi: 10.2214/AJR.14.12518. PMID 25055291