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Glutamate Inhibitors in Glioblastoma

NCT05664464 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-05-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Gabapentin

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

DRUG

Sulfasalazine

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

DRUG

Memantine

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

DRUG

Temozolomide

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

RADIATION

Radiotherapy

30 x 2 Gy involved field radiotherapy with concomitant temozolomide

Sponsors & Collaborators

  • Swiss National Science Foundation

    collaborator OTHER

  • University of Zurich

    lead OTHER

Principal Investigators

  • Hans-Georg Wirsching, MD · University Hospital and University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664464 on ClinicalTrials.gov