The aim of this 1:1 randomized, multicenter, open-label phase Ib/II clinical trial is to investigate the efficacy of adding the antiglutamatergic drugs gabapentin, sulfasalazine and memantine to standard chemoradiotherapy with temozolomide compared to chemoradiotherapy alone in patients with newly diagnosed glioblastoma.
Aim of the study
We want to investigate how effective and well tolerated a combination of the drugs gabapentin, sulfasalazine and memantine is as an addition to standard therapy for glioblastoma (brain tumor). Gabapentin, sulfasalazine and memantine are not yet approved for the treatment of this disease in Switzerland.
Who can take part?
Patients with glioblastoma
Procedure
This clinical trial is divided into 3 phases: Pre-trial phase, treatment phase and follow-up phase. Preliminary examination phase: Before you are enrolled in this clinical trial, your medical history will be taken and you will undergo a comprehensive medical examination. Treatment phase: A few weeks after the operation, you will start the standard treatment with radiotherapy and temozolomide as chemotherapy. This corresponds to the routine treatment of patients with your disease. This has already been explained to you in detail by your study doctor. Together with radiotherapy and chemotherapy, therapy with gabapentin, sulfasalazine and memantine will also be started in the experimental arm of the study. End of treatment and follow-up phase: Reasons for ending treatment with the study medication may be that a new tumor growth has been detected, that you do not tolerate the medication, or that you decide against study treatment without having to give reasons for this. When your treatment with the study medication ends, a comprehensive medical examination will take place within 14 days, as with all regular study visits during the treatment phase.
Compensation
None
Original study name
A randomized, open-label phase Ib/II study of repurposing glutamate signaling inhibitors in combination with chemoradiotherapy in patients with newly diagnosed glioblastoma (GLUGLIO)
BASEC number
2022-01877
Financial support from
University of Zurich