Clinical trial · Interventional
Glutamate Inhibitors in Glioblastoma
A Phase Ib/II Randomized, Open Label Drug Repurposing Trial of Glutamate Signaling Inhibitors in Combination With Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
NCT05664464CI-TRIAL-00077041GLUGLIOrecruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The goal of this 1:1 randomized, multi-center, open-label phase Ib/II clinical trial is to explore the efficacy of the add-on of the anti-glutamatergic drugs gabapentin, sulfasalazine and memantine to standard chemoradiotherapy with temozolomide compared to chemoradiotherapy alone in patients with newly diagnosed glioblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gabapentin | Drug | — | UNRESOLVED |
| Memantine | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Sulfasalazine | Drug | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of care
- description
- Radiotherapy 30 x 2 Gy with concomitant temozolomide followed by maintenance temozolomide
- interventionNames
- Drug: Temozolomide
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Standard of care plus glutamate signaling inhibitors
- description
- Radiotherapy 30 x 2 Gy with concomitant temozolomide followed by maintenance temozolomide plus combined daily gabapentin, sulfasalazine and memantine
- interventionNames
- Drug: Gabapentin
- Drug: Sulfasalazine
- Drug: Memantine
- Drug: Temozolomide
- Radiation: Radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Diagnosis: Newly diagnosed supratentorial glioblastoma according to the 2021 World Health Organization (WHO) Classification of Central Nervous System Tumors * Signed informed consent * Age \>18 years * Eligible for standard chemoradiotherapy with temozolomide (TMZ/RT-\>TMZ, hypofractionated RT regimen not allowed) * KPS 70 or more * Ability to judge per local investigator estimate (at least oriented to time, place and situation) * Paraffin-embedded tissue for central pathology review * Adequate heamatological, liver and renal function Exclusion criteria * Scheduled for hypofractionated radiotherapy * Women who are pregnant or breast feeding, * Intention to become pregnant during the course of the study or intention to father a child, * Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential. * Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease), * Known or suspected non-compliance, drug or alcohol abuse, * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Previous enrolment into the current study, * Being an investigator, his/her family members, employees and other dependent persons, * Any prior radiotherapy of the brain or radiotherapy with potential overlap of the irradiation fields, * Active malignancy that may interfere with the study treatment, * Abnormal ECG with QTc \>450 ms, * Contraindication for Gadolinium-enhanced MRI, * Previous intolerance reactions to one of the study drugs, * Intolerance reactions to sulfonamides or salicylates, * Acute intermittend porphyria, * Known glucose-6-phosphate dehydrogenase deficiency, * Concomitant therapy with digoxin, cyclosporin, methotrexate, * History of exfoliative dermatitis, Stevens-Johnson-Syndrome, toxic epidermal necrolysis, DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) syndrome or renal tubular acidosis.
References
Publications (1)
- BACKGROUNDMastall M, Roth P, Bink A, Fischer Maranta A, Laubli H, Hottinger AF, Hundsberger T, Migliorini D, Ochsenbein A, Seystahl K, Imbach L, Hortobagyi T, Held L, Weller M, Wirsching HG. A phase Ib/II randomized, open-label drug repurposing trial of glutamate signaling inhibitors in combination with chemoradiotherapy in patients with newly diagnosed glioblastoma: the GLUGLIO trial protocol. BMC Cancer. 2024 Jan 15;24(1):82. doi: 10.1186/s12885-023-11797-z. PMID 38225589