Status:
TERMINATED
Sequential Intravesical Bacillus Calmette-Guérin and Electromotive Mitomycin-C After Transuretheral Resection
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Rutgers Cancer Institute of New Jersey
Conditions:
Bladder Carcinoma
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- After a restaging TURBT patients with histologically proven primary high grade (grade3) and/or pT1 transitional cell carcinoma of the bladder, with or without pTis and pTis alone are regarded as being at high risk for tumour recurrence and progression.
- Patients may enroll in this study if they are thought to have no residual disease after TURBT.
- Age 18 years or over
- Adequate bone-marrow reserve- ECOG performance status between 0 and 2
- Patients who are known PPD positive will be screened for active tuberculosis prior to starting treatment with BCG.
Exclusion
- known allergy to BCG or MMC
- prior systemic infection with BCG
- prior or concomitant urothelial tumours of the upper urinary tract or urethra
- previous muscle-invasive (ie, stage T2 or higher) transitional-cell carcinoma of the bladder
- bladder capacity of less than 200 ml
- untreated urinary-tract infection
- severe systemic infection (ie, sepsis)
- known HIV-positivity; therapy with immunosuppressive agents
- urethral strictures that would prevent endoscopic procedures and repeated catheterisation
- upper urinary tract disease (eg, vesicoureteral reflux or urinary-tract stones) that would make multiple transurethral procedures a risk
- previous radiotherapy to the pelvis
- other concurrent chemotherapy
- treatment with radiotherapy-response or biological-response modifiers
- history of tuberculosis;
- other malignant diseases within 5 years of trial registration (except for adequately treated basal-cell or squamous cell skin cancer, in situ cervical cancer and any other cancer from which patients has been disease-free for 3 years);
- pregnancy or nursing
- psychological, familial, sociological, or geographical factors that would preclude study participation.
- Patients with implantable or wearable electrical devices will be excluded from this study.
- Patients with active tuberculosis
Key Trial Info
Start Date :
February 24 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2016
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02202044
Start Date
February 24 2015
End Date
May 11 2016
Last Update
June 14 2019
Active Locations (2)
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1
Donald Lam, MD
Phoenix, Arizona, United States, 85032
2
University of Colorado Denver
Aurora, Colorado, United States, 80045