Sequential Intravesical Bacillus Calmette-Guérin and Electromotive Mitomycin-C After Transuretheral Resection

Stopped early · Not applicable

Conditions studied: Bladder Carcinoma

In brief

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).

Key facts

Study ID

NCT02202044

Run by

University of Colorado, Denver

People needed

13

Starts

2015-02-24

Expected to finish

2016-05-11

Last updated by the study team

2019-06-14

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Donald Lam, MD — Phoenix, Arizona, United States
• University of Colorado Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.