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NCT05664464Recruiting

Glutamate Inhibitors in Glioblastoma

Summary

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.

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.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 1 · Phase 2
Study type
Interventional
Countries
Switzerland
Sponsor
University of Zurich(Other)
Protocol no.
2022-01877
Conditions
Glioblastoma
Interventions
Drug, Radiation

Treatments studied

  • Gabapentin
  • Sulfasalazine
  • Memantine
  • Temozolomide
  • Radiotherapy

Collaborators

Swiss National Science Foundation

Locations · 1

  • Zurich, SwitzerlandUniversity Hospital ZurichRecruiting at this site

In total, worldwide, the only site listed in the registry is recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: May 10, 2024).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.