Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids

PHASE2RecruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

February 21, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2027

Conditions
Bladder CancerNon-muscle Invasive
Interventions
DRUG

Epirubicin

"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."

DRUG

Mitomycin

"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"

DRUG

Gemcitabine

"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."

DRUG

Docetaxel

"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."

Trial Locations (1)

2501

RECRUITING

Spitalzentrum Biel/Bienne, Biel

All Listed Sponsors
collaborator

University of Bern

OTHER

collaborator

Hospital Centre Biel/Bienne

OTHER

lead

Roland Seiler-Blarer

OTHER