At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Signed Informed Consent Form
- ✓ECOG performance status 0 or 1
- ✓Histologically confirmed intermediate risk non-muscle-invasive urothelial carcinoma of the bladder (pTa low grade)
- ✕Known previous high grade and/or high risk non-muscle-invasive bladder cancer
- ✕Previous intravesical BCG therapy
- ✕Pregnancy or nursing
- ✕Significant uncontrolled concomitant disease affecting protocol compliance
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05024734Phase 2RecruitingUpdate OverdueUpdated 15mo ago · Completion was 8mo agoGuidance of Adjuvant Instillation in Intermediate Risk Non-muscle Invasive Bladder Cancer by Drug Screens in Patient Derived Organoids. A Single Center, Open-label, Phase II Trial With a Feasibility Endpoint. (GAIN-INST-TRIAL)
In Brief
A Phase 2 clinical trial evaluating Epirubicin, Mitomycin, and 2 other interventions for Bladder Cancer and Non-muscle Invasive. Currently recruiting, targeting 34 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Interventions
In PDOs from patients that show highest response to Epirubicin, this drug will be instilled intravesically once weekly for 6 times. Epirubicin is also the default drug, in case of failure of drug prediction in the in-vitro drug screen in PDO. Epirubicin will be used as a concentrate for injection/instillation 2 mg/ml in total 50mg per vial. Prior to use, the concentrate for injection is diluted with 25ml of 0.9% saline solution to obtain the final Solution with 1mg/ml of Epirubicin.
In PDOs from patients that show highest response to Mitomycin, this drug will be instilled intravesically once weekly for 6 times. Mitomycin C will be used as 20mg dry powder. Prior to use, the powder will be dissolved in 50ml of 0.9% saline solution according to the manufacturer instructions
In PDOs from patients that show highest response to Gemcitabine, this drug will be instilled intravesically once weekly for 6 times. Gemcitabine will be used as 2000 mg/50ml. For intravesical application, 1000mg of gemcitabine (corresponding to 25ml) will be diluted in 25ml 0.9% saline solution, to obtain the gemcitabine concentration of 1000mg/50ml used for instillation.
In PDOs from patients that show highest response to Docetaxel, this drug will be instilled intravesically once weekly for 6 times. Docetaxel will be used as 140mg/7ml solution. For intravesical application, 48.825ml of saline will be added to 1.875ml Docetaxel solution (according 37.5mg of Docetaxel). The concentration of this solution is 0.74mg/ml by a total volume of the instillation solution of 50,7.