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

NCT02202044 | Terminated Results

• 1 other identifier: 14-1359.cc
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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 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).

Conditions

Bladder Carcinoma

Keywords

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• To Assess Disease Recurrence Rate

  5 years

Secondary Outcomes (1)

• To Compare Complete Response Rates at 3 and 6 Months in Patients With Carcinoma in Situ.

  5 years

Other Outcomes (2)

• To Compare the Qualitative and Quantitative Toxicities of Experimental Regimens in These Patients.

  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)

  5 years

Study Arms (1)

Intravesical BCG and EMDA/MMC

EXPERIMENTAL

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

Interventions

Intravesical BCG and EMDA/MMC DEVICE

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

Intravesical BCG and EMDA/MMC

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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);

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (2)

Donald Lam, MD

Phoenix, Arizona, 85032, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Tracey MacDermott
• Organization: University of Colorado

Tracey.MacDermott@ucdenver.edu

303-724-2757

Study Officials

• Shandra Wilson, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 28, 2014
• Study Start: February 24, 2015
• Primary Completion: May 11, 2016
• Study Completion: May 11, 2016
• Last Updated: June 14, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)