Actively Recruiting
Glutamate Inhibitors in Glioblastoma
Led by University of Zurich · Updated on 2024-05-10
120
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
U
University of Zurich
Lead Sponsor
S
Swiss National Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Glutamate Inhibitors in Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed supratentorial glioblastoma as defined by 2021 WHO CNS tumor classification
- Signed informed consent
- Age over 18 years
- Eligible for standard chemoradiotherapy with temozolomide (no hypofractionated radiotherapy)
- Karnofsky Performance Score of 70 or higher
- Ability to understand and judge according to local investigator
- Availability of paraffin-embedded tumor tissue for central pathology review
- Adequate blood counts, liver and kidney function
You will not qualify if you...
- Scheduled for hypofractionated radiotherapy
- Pregnant or breastfeeding women
- Intention to become pregnant or father a child during the study
- Lack of safe contraception in women of childbearing potential
- Other significant diseases such as renal failure, liver dysfunction, or cardiovascular disease
- Known or suspected drug or alcohol abuse
- Inability to follow study procedures due to language, psychological, or cognitive issues
- Participation in another investigational drug study within 30 days
- Previous enrollment in this study
- Being an investigator or related to study personnel
- Prior brain radiotherapy or overlapping radiation fields
- Active cancer interfering with study treatment
- Abnormal ECG with QTc over 450 ms
- Contraindication to gadolinium-enhanced MRI
- Known intolerance to study drugs or related compounds
- Acute intermittent porphyria
- Glucose-6-phosphate dehydrogenase deficiency
- Concomitant treatment with digoxin, cyclosporin, or methotrexate
- History of severe skin reactions or renal tubular acidosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8090
Actively Recruiting
Research Team
H
Hans-Georg Wirsching, MD
CONTACT
M
Michael Weller, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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