Clinical trial · Interventional
Phase I Pilot Study to Evaluate the Anti-glioblastoma Effect of S-Gboxin in Standard Treatment of Glioblastoma/Diffuse Midline Glioma and Response to Treatment (Regardless of Mutation Status)
NCT06806228CI-TRIAL-00113516suspendedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study protocol will be changed
Summary
Brief summary (as posted)
The objective of this pilot study is to evaluate the efficacy of adding S-Gboxin to standard RT/TMZ treatment protocols in patients with glioblastoma multiforme (GBM) or midline glioma (DMG), regardless of their mutation status
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Midline Glioma, H3 K27M-Mutant | Diffuse Midline Glioma, H3 K27M-Mutant | ONTOLOGY_EXACT | 0.98 |
| GBM | Glioblastoma | ALIAS | 0.90 |
| Giant Cell Glioblastoma | Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.90 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Gliosarcoma | Gliosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-Gboxin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients will be offered 4 courses of Gboxin during (or without) standard treatment.
- description
- Patients will be offered 4 courses of S-Gboxin during standard treatment. Each course (18 days) consists of twice daily intake of S-Gboxin for 14 days and four days of rest. Each dose of S-Gboxin is packed in a gelatin capsule with a bandage and applied markings.
- interventionNames
- Biological: S-Gboxin
Primary outcomes (1)
- measure
- Brain tumor metabolism as measured by PET and MRI
- timeFrame
- Up to 6 month
- description
- The standardized uptake value (SUV) of HGG will be measured. SUV is a standard PET measurement. MRI with contrast will evaluate the change in tumor size before and after therapy S-Gboxin
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * confirmed diagnosis of Glioblastoma according to RANO criteria by contrast-enhanced MRI or PET-CT (including diffuse midline glioma, gliosarcoma or giant cell glioblastoma), relapse or disease progression * patient is able to understand and give consent to participate in the study * Karnofsky performance score ≥ 60 * women of childbearing potential must have a negative pregnancy test result no later than 7 days before registration Exclusion Criteria: * pregnant * known allergies * active treatment on annotner clinical trial * inability to complete with protocol or studio procedures.
References
Publications (0)
Data not yet available
No reference posted for this study.