JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05024734

Studienbeginn:
November 2022

Letztes Update:
22.11.2022

Wirkstoff:
Epirubicin, Mitomycin, Gemcitabine, Docetaxel

Indikation (Clinical Trials):
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Insel Gruppe AG, University Hospital Bern

Collaborator:
University of Bern, Hospital Centre Biel/Bienne,

Studienleiter

Roland Seiler, MD
Study Chair
Department of Urology

Kontakt

Roland Seiler, MD
Kontakt:
Phone: +4132 324 32 06
E-Mail: urologie@szb-chb.ch» Kontaktdaten anzeigen

Saskia Wehrli, MSc
Kontakt:
Phone: +4132 324 32 06
E-Mail: urologie@szb-chb.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Roland Seiler
2501 Biel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Roland Seiler, Prof.
Phone: +41 32 324 24 24
E-Mail: r_seiler@gmx.ch» Ansprechpartner anzeigen

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age ≥ 18 years

- Signed Informed Consent Form

- ECOG performance status of 0 or 1

- Histologically confirmed intermediate risk non muscle-invasive urothelial carcinoma of

the bladder (pTa low grade) Patients

- Representative fresh tumor specimen for PDO generation and drug screen

Exclusion Criteria:

- Known previous high grade and/or high risk non muscle-invasive bladder cancer

- Previous Intravesical biological/immuno (BCG) therapy

- Pregnancy or nursing

- Evidence of significant uncontrolled concomitant disease that could affect compliance

with the protocol

- Severe infection within 4 weeks prior to cycle 1, day 1

- Contraindication for frequent catheterization

- Voiding dysfunction

Studien-Rationale

Primary outcome:

1. Number of patients with successful drug selection (Time Frame - 24 months):
● To determine the proportion of patients for which a suitable treatment can be identified by drug screens in patient derived organoids This will establish the use of drug screens in PDOs in clinical setting and their implementation in clinical trials.

Secondary outcome:

1. Side effects (Time Frame - 24 months):
Number of patients with side effects

2. Recurrence rate (Time Frame - 42 months):
Number of patients with recurrence

3. QoL (Time Frame - 42 months):
Quality of life will be determined using the SF-36 questionnaire

Studien-Arme

Experimental: Epirubicin
Patients in that PDOs show highest response to this drug in-vitro will be treated with Epirubicin. If no significant drug selection can be performed in-vitro, Epirubicin will be the default for instillation.
Experimental: Mitomycin
Patients in that PDOs show highest response to this drug in-vitro will be treated with Mitomycin.
Experimental: Gemcitabine
Patients in that PDOs show highest response to this drug in-vitro will be treated with Gemcitabine.
Experimental: Docetaxel
Patients in that PDOs show highest response to this drug in-vitro will be treated with Docetaxel.

Geprüfte Regime

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.
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
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.
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.

Quelle: ClinicalTrials.gov

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