RecruitingPhase 1Phase 2NCT05664464

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


Sponsor

University of Zurich

Enrollment

120 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding glutamate inhibitors (drugs that block a brain chemical called glutamate) to standard treatment improves outcomes for people with newly diagnosed glioblastoma — the most serious type of brain tumor. Standard treatment includes surgery, radiation, and a chemotherapy called temozolomide. **You may be eligible if...** - You are over 18 years old - You have been newly diagnosed with glioblastoma (as defined by 2021 WHO criteria) - You are eligible for standard chemoradiotherapy with temozolomide - Your performance score (Karnofsky Performance Status) is 70 or higher — meaning you can carry out normal activities with some effort - Your blood, liver, and kidney function are within acceptable ranges - Tumor tissue is available for central review **You may NOT be eligible if...** - You are scheduled for a shorter, hypofractionated radiation regimen - You are pregnant or breastfeeding, or planning a pregnancy - You have other significant medical conditions (serious kidney, liver, or heart disease) - You have a known allergy to the study drugs - You are unable to use effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGabapentin

Weekly dose escalations over 4 weeks of daily 3 x 300 mg up to 3 x 1200 mg

DRUGSulfasalazine

Weekly dose escalations over 3 weeks of daily 3 x 500 mg up to 3 x 1500 mg

DRUGMemantine

Weekly dose escalations over 4 weeks of daily 1 x 5-20 mg

DRUGTemozolomide

Concomitant with radiotherapy at 75 mg/m2 daily followed by maintenance 150-200 mg/m2 on 5/28 days

RADIATIONRadiotherapy

30 x 2 Gy involved field radiotherapy with concomitant temozolomide


Locations(1)

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

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NCT05664464


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