Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer
Open-label, Multi-center Study of the Efficacy and Safety of MCC in the Treatment of Patients With Non-muscle Invasive (Superficial) Bladder Cancer at High Risk of Progression and Who Are Refractory to BCG
1 other identifier
interventional
129
2 countries
31
Brief Summary
The purpose of this study is to determine the efficacy and safety of intravesical Mycobacterial Cell Wall-DNA Complex (MCC) in patients with non-muscle invasive transitional cell carcinoma (papillary tumors and/or carcinoma in situ) of the urinary bladder at high risk of progression who are refractory to therapy with bacillus Calmette-Guerin (BCG).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2006
Longer than P75 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 1, 2006
CompletedFirst Posted
Study publicly available on registry
December 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJuly 28, 2016
July 1, 2016
4.7 years
December 1, 2006
July 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
One year disease-free survival rate
Prospective
Secondary Outcomes (5)
The 3, 6 and 24 month disease-free survival rate
Prospective
Duration of disease-free survival in all patients
Prospective
Time to progression to muscle invasive disease
Prospective
Overall survival in all patients
Prospective
Rate of overall drug-related adverse events leading to two consecutive treatment delays of one week each or to the discontinuation of treatment.
Prospective
Study Arms (1)
Mycobacterial cell wall-DNA complex
EXPERIMENTALMycobacterial cell wall-DNA complex
Interventions
8 mg MCC, intravesical - Induction Phase (6 weekly intravesical instillations) and Maintenance Phase (3 weekly instillations at months 3, 6, 12, 18 and 24).
Eligibility Criteria
You may qualify if:
- Patients refractory to BCG therapy;
- Patients with histologically confirmed diagnosis of high grade lesions;
- Diagnosis of high grade lesion must be within 56 days prior to beginning of study treatment;
- Have had all visible papillary lesion(s) resected by TURBT within 56 days prior to beginning of study treatment;
- Available for the whole duration of the study including follow-up (60 months);
- Life expectancy of \> 5 years;
- Patients with an ECOG performance status grade of 2 or less;
- Absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from beginning of study treatment;
- Able to understand and give written informed consent;
- In the investigator's judgment, the patient is able to participate in the study.
You may not qualify if:
- Current or previous history of muscle invasive tumors;
- Current or previous history of lymph node or distant metastases from bladder cancer;
- Current systemic cancer therapy;
- Current or prior pelvic external beam radiotherapy;
- Pelvic brachytherapy within 2 years of study entry;
- Prior treatment with MCC;
- Patients with existing urinary tract infection or recurrent severe bacterial cystitis;
- Clinically significant and unexplained elevations of liver or renal function tests;
- White blood cell count below 3 x109/L (3,000/mm3) or platelet count below 100 x 109/L(100,000/mm3);
- Severe cardiovascular disease;
- Women who are pregnant or lactating;
- Congenital or acquired immune deficiency;
- With history of malignancy of any organ system, treated or untreated, within the past 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, stage T1 prostate cancer, carcinoma in situ of the cervix or colon polyps);
- Previous investigational treatment within 3 months from beginning of study treatment;
- Patients who cannot hold the instillation for one hour;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
BCG Oncology
Phoenix, Arizona, 85032, United States
San Diego Clinical Trials
San Diego, California, 92120, United States
Connecticut Urological Research at Grove Hill
New Britain, Connecticut, 06052, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
Winter Park Urology Associates P.A.
Orlando, Florida, 32803, United States
The University of Chicago Hospitals
Chicago, Illinois, 60637, United States
Welborn Clinic
Evansville, Indiana, 47713, United States
Johns Hopkins University
Baltimore, Maryland, 21231, United States
Chesapeake Urology Research Associates
Towson, Maryland, 21204, United States
Sheldon J Freedman, MD, Ltd
Las Vegas, Nevada, 89148, United States
Delaware Valley Urology, LLC-Voorhees
Voorhees Township, New Jersey, 08043, United States
Memorial Sloan Kettering Cancer Centre
New York, New York, 10021, United States
Hudson Valley Urology
Poughkeepsie, New York, 12601, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Triangle Urology Group
Pittsburgh, Pennsylvania, 15212, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Urology Clinics of North Texas, P.A.
Dallas, Texas, 75231, United States
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Urology San Antonio Research, PA
San Antonio, Texas, 78229, United States
Sentara Medical Group - Urology of Virginia, PC
Norfolk, Virginia, 23502, United States
Andreou Research
Surrey, British Columbia, V3V 1N1, Canada
Can-Med Clinical Research
Victoria, British Columbia, V8T 5G1, Canada
Dr. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1, Canada
Centre for Applied Urological Research
Kingston, Ontario, K7L 3J7, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network / Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
The Male Health Center
Toronto, Ontario, M6A 3B5, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3J4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Centre de Recherche du CHUQ
Québec, Quebec, G1R 2J6, Canada
Related Publications (1)
Morales A, Herr H, Steinberg G, Given R, Cohen Z, Amrhein J, Kamat AM. Efficacy and safety of MCNA in patients with nonmuscle invasive bladder cancer at high risk for recurrence and progression after failed treatment with bacillus Calmette-Guerin. J Urol. 2015 Apr;193(4):1135-43. doi: 10.1016/j.juro.2014.09.109. Epub 2014 Oct 5.
PMID: 25286009RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alvaro Morales, MD
Centre for Applied Urological Research, Kingston General Hospital/Queen's University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2006
First Posted
December 4, 2006
Study Start
November 1, 2006
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
July 28, 2016
Record last verified: 2016-07