Sequential Intravesical Bacillus Calmette-Guérin and Electromotive Mitomycin-C After Transuretheral Resection
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|ClinicalTrials.gov Identifier: NCT02202044|
Recruitment Status : Terminated (The institution was requiring extensive changes to the protocol)
First Posted : July 28, 2014
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
The primary objective of the study is to assess the bladder cancer recurrence free rate, according to a phase II pilot study, of intravesical instillation of sequential BCG and EMDA/MMC after TUR. The study is designed as a one-sample investigation: the outcome measure is disease recurrence rate. Follow up will continue up to 5 years.
For sample size determination, disease recurrence rate will be compared with literature data of recurrence rate obtained in standard BCG alone administration (Lamm's protocol).
|Condition or disease||Intervention/treatment||Phase|
|Bladder Carcinoma||Device: Intravesical BCG and EMDA/MMC||Not Applicable|
TURBT (TransUrethral Resection of Bladder Tumor)
Prior to enrolment, all patients must sign a consent form and will have a Complete Blood Count (CBC), Basic Metabolic Panel (BMP) and a Urinalysis (UA) performed. The patients White Blood Count (WBC) must be greater than 4.0 10^9/L and platelet count greater than 150 10^9/L to receive drug.
Week 1, 2, 4, 5, 7 and 8: BCG instillation: 50 mg wet weight (10•2±9•0x108 colony-forming units) BCG Connaught substrain. Lyophilised (ie, freeze-dried) BCG are suspended in 50 ml bacteriostatic-free 0.9% Sodium Chloride (NaCl) solution. After bladder draining, the suspension is infused intravesically through a 14 Fr Foley catheter and retained in the bladder for 60-90 min; bladder emptying is followed by catheter removal.
Week 3, 6 and 9: A Foley catheter is inserted and the bladder is carefully drained. 40 mg MMC dissolved in 100 ml NaCl 0.9% solution are instilled intravesically through the electrode catheter by gravity and retained in the bladder for 30 min, while 23 mA for 30 min pulsed electric current is given externally. Two dispersive cathode electrodes are placed on lower abdominal skin after degreasing with alcohol. The bladder is then emptied and the catheter removed. Patients are assigned one course of treatment per week for 6 weeks with sequential BCG and EMDA/MMC. Two BCG instillations and one EMDA/MMC instillation constitute one cycle for a total of two cycles.
A CBC and basic metabolic panel (BMP) will be performed weekly and at the beginning of each cycle. Prior to dosing with mitomycin C at week 3, a CBC will be performed and also at weeks 4 and 5 if the CBC has changed. A UA will be performed prior to each intravesicular instillation.
Maintenance treatment of eMMC will be given at month 3, 4, 6, 7, 9 and 10 (after last dose of BCG of the initial treatment). Maintenance of BCG will be given around month 5, 8, and 11. CBC, BMP, UA, and a history/physical (H&P) will be performed before each EMDA/MMC procedure. UA and a H&P will be performed before each BCG.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Sequential Intravesical BCG (Bacillus Calmette-Guérin) and Electromotive Mitomycin-C (EMDA/MMC) After Transuretheral Resection (TUR) in Patients With Primary High Risk Non-Muscle Invasive Transitional Cell Carcinoma of the Bladder|
|Actual Study Start Date :||February 24, 2015|
|Actual Primary Completion Date :||May 11, 2016|
|Actual Study Completion Date :||May 11, 2016|
Experimental: Intravesical BCG and EMDA/MMC
Patients are assigned one course of treatment per week for 6 weeks of Intravesical Intravesical BCG and EMDA/MMC
Device: Intravesical BCG and EMDA/MMC
Patients are assigned one course of treatment per week for 6 weeks with sequential 'Intravesical instillation of sequential Bacillus Calmette-Guérin (BCG) and Electromotive Drug Administration /Mitomycin-C
- To Assess Disease Recurrence Rate [ Time Frame: 5 years ]
- To Compare Complete Response Rates at 3 and 6 Months in Patients With Carcinoma in Situ. [ Time Frame: 5 years ]
- To Compare the Qualitative and Quantitative Toxicities of Experimental Regimens in These Patients. [ Time Frame: 5 years ]
- To Assess Long-term Morbidity in the Study Group, as Defined by Requirement for Fewer TURBTs, Courses of Traditional Intravesical Therapies, and Surveillance Cystoscopies Over 5 Years (Cost-effectiveness) [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202044
|United States, Arizona|
|Donald Lam, MD|
|Phoenix, Arizona, United States, 85032|
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Shandra Wilson, MD||University of Colorado, Denver|