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

Roland Seiler-Blarer

Status and phase

Enrolling

Phase 2

Conditions

Bladder Cancer

Non-muscle Invasive

Treatments

Drug: Gemcitabine

Drug: Mitomycin

Drug: Epirubicin

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT05024734

SZB-URO-21-001

Details and patient eligibility

About

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.

Enrollment

34 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Pregnancy or nursing
Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 6 months after the last treatment.
Male subject who is unwilling to use acceptable method of effective contraception during IP treatment and through 6 months after the last dose of IP.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 4 patient groups

Epirubicin

Experimental group

Description:

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.

Treatment:

Drug: Epirubicin

Mitomycin

Experimental group

Description:

Patients in that PDOs show highest response to this drug in-vitro will be treated with Mitomycin.

Treatment:

Drug: Mitomycin

Gemcitabine

Experimental group

Description:

Patients in that PDOs show highest response to this drug in-vitro will be treated with Gemcitabine.