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Precise Chemoresection in Low-grade NMIBC Using Drug Screens in Patient-derived Organoids

ConditionsBladder CancerNon-muscle Invasive Bladder CancerLow Grade
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Centre Biel/Bienne

About this trial

Based on the unmet clinical need to reduce invasiveness of treatment of low grade NMIBC, the investigators conduct this prospective, open label, single arm and single center phase II trial. The investigators aim to use drug screens in PDOs to guide neoadjuvant intravesical instillation therapy with either Epirubicin, Mitomycin C, Gemcitabine or Docetaxel to achieve chemoresection NMIBC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed Informed Consent Form

Age ≥ 18 years

Primary or recurrent NMIBC suspected to be low-grade or maximum G2 with a negative urine cytology

Disqualifiers

Anticoagulation other than acetylsalicylic acid

Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol as judged by the investigator

Severe infection within 4 weeks prior to the date of the patient's informed consent signature

Contraindication for frequent catheterization

Trial design

Design model

Single group

Treatments tested in this trial

  • Epirubicin

    Drug

    In PDOs from patients that show highest response to Epirubicin, this drug will be instilled intravesically once weekly for 6 times. 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

    Drug

    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

    Drug

    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

    Drug

    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.

Treatment groups

28 Participants
are divided into 4 treatment groups
Group A: EpirubicinExperimental treatment 1 intervention
Group B: MitomycinExperimental treatment 1 intervention
Group C: GemcitabineExperimental treatment 1 intervention
Group D: DocetaxelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathological response

Rate of patients that show complete pathological response to neoadjuvant chemoresection

Time frame
15 weeks

Secondary outcomes

1

Feasibility of drug screen

Rate of patients in which drug screen in patient derived organoids was successful

Time frame
4 weeks
2

Safety of the study intervention

Incidence, severity and type of Adverse Events of Special Interest (AESIs) which are defined as adverse events related to chemotherapeutic intravesical instillation. AESIs include dysuria, urinary tract infections, and complications due to catheterism for intravesical instillation such as urethral irritation and haematuria

Time frame
12 weeks
3

Number of patients with recurrence free survival

Recurrence after neoadjuvant chemoresection and transurethral resection of the bladder tumor

Time frame
1 Year
4

Tolerability of instillation

Quality of life measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). It corresponds to a functional Scales \& Global Health Status; a higher score indicates a better outcome (a higher level of functioning or a better quality of life). The score minimum is 0 and maximum 100.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Centre Biel/Bienne

Lead sponsor

Spitalzentrum Biel

Collaborator

Lindenhofgruppe AG

Collaborator

Fond'action contre le cancer

Collaborator

Source ClinicalTrials.gov

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