Intravesical Instillation Therapy With Bacillus Calmette-Guérin (BCG) and Sequential BCG and Electromotive Mitomycin-C (EMDA-MCC) in Patients With High-risk Non-muscle-invasive Bladder Carcinoma

Who is this study for? Patients with high risk Non-Muscle-Invasive Bladder Cancer
What treatments are being studied? Bacillus of Calmette-Guerin
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Disease recurrence and progression is a major issue in high risk non-muscle-invasive bladder cancer (NMIBC). The current study compares two adjuvant instillation therapies in the treatment of high risk NMIBC. After resection of the tumour(s), patients will receive either traditional regimen of Bacillus Calmette-Guérin (BCG) instillations or combination treatment consisting of sequential BCG-instillations and mitomycin C instillations administered with electromotive drug administration (EMDA) device.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically proven non-muscle-invasive tumour types confined to the urinary bladder

• Carcinoma in situ with or without a papillary tumour(s)

• Ta tumour(s) of high-grade

• Any T1 tumour(s)

• Written informed consent is required from every eligible patient

• Second resection performed in case of T1 tumour

• Adequate physical and mental condition to participate in the study (as judged by treating physician

Locations
Other Locations
Finland
HYKS Peijas Hospital
RECRUITING
Helsinki
Jyväskylä Central Hospital
RECRUITING
Jyväskylä
Päijät-Häme Central hospital
RECRUITING
Lahti
Mikkeli Central Hospital
RECRUITING
Mikkeli
Seinäjoki Central Hospital
RECRUITING
Seinäjoki
Tampere University Hospital
RECRUITING
Tampere
Turku University Hospital
RECRUITING
Turku
Contact Information
Primary
Pertti T Nurminen, MD
pertti.nurminen@tyks.fi
+358 2 3135922
Backup
Riikka Järvinen, MD, PhD
riikka.jarvinen@hus.fi
+358 50 427 1015
Time Frame
Start Date: 2018-10-26
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 300
Treatments
Active_comparator: Group A
BCG instillation therapy with induction period of six weekly instillations of BCG followed by maintenance period of ten monthly instillations of BCG~Dosage of Bacillus of Calmette-Guerin (BCG) is dependent on the preferred brand of BCG by the participating institution. Either 2 x 10\^8 - 3 x 10\^9 for BCG-MEDAC, 2-8 x 10\^8 colony forming unit for OncoTICE or, 81mg for ImmuCYST and TheraCys. The investigators will nominate which BCG brand is used.
Experimental: Group B
Sequential BCG and EMDA mitomycin C treatment with nine weekly instillations of BCG, BCG, EMDA-MMC x3 followed by nine monthly instillations of EMDA-MMC, EMDA-MMC, BCG x3~Dosage of Bacillus of Calmette-Guerin (BCG) is dependent on the preferred brand of BCG by the participating institution. Either 2 x 10\^8 - 3 x 10\^9 for BCG-MEDAC, 2-8 x 10\^8 colony forming unit for OncoTICE or, 81mg for ImmuCYST and TheraCys. The investigators will nominate which BCG brand is used.~Mitomycin C dosage is 40 mg of MMC with 960 mg of excipient sodium chloride dissolved in 100 ml sterile water
Related Therapeutic Areas
Sponsors
Collaborators: Finnbladder
Leads: Turku University Hospital

This content was sourced from clinicaltrials.gov

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