drugset / Trial / NCT05024734
Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids
Phase 2
Active not recruiting
31 enrolled
Roland Seiler-Blarer
Hospital Centre Biel/Bienne · collabUniversity of Bern · collab
NaSingle-groupOpen-labelTreatment
Summary
From patients with intermediate risk non-muscle invasive bladder cancer tumor (NMIBC) specimens will be harvested during transurethral resection. Fresh specimens will be cultured as patient derived organoids (PDO). After approx. 10 days, PDO are exposed to different drugs that are used as intravesical instillation agents in these patients (epirubicin, mitomycin, gemcitabine, docetaxel). After 2 days of exposure, PDO viability will be measured. The drug with the highest antitumor effect on PDO will be applied as weekly intravesical instillations 6 times. Thereafter, patients are followed according to the standard of care.
Timeline
- Start
- 2023-02-21
- Primary completion
- 2026-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 37.5 mg | Intrathecal |
| Subject | Epirubicin | Small molecule | 50 mg | Intrathecal |
| Subject | Gemcitabine | Small molecule | 1000 mg | Intrathecal |
| Subject | Mitomycin C | Other / unclassified | 20 mg | Intrathecal |