Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer

Completed · Phase 2/Phase 3

Conditions studied: Bladder Neoplasms

In brief

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).

Key facts

Study ID

NCT00406068

Run by

Bioniche Life Sciences Inc.

People needed

129

Starts

2006-11-01

Expected to finish

2011-07-01

Last updated by the study team

2016-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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;
• Patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy);
• Clinically significant active infections;
• Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol.

Where it is running

• BCG Oncology — Phoenix, Arizona, United States
• San Diego Clinical Trials — San Diego, California, United States
• Connecticut Urological Research at Grove Hill — New Britain, Connecticut, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Winter Park Urology Associates P.A. — Orlando, Florida, United States
• The University of Chicago Hospitals — Chicago, Illinois, United States
• Welborn Clinic — Evansville, Indiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Chesapeake Urology Research Associates — Towson, Maryland, United States
• Sheldon J Freedman, MD, Ltd — Las Vegas, Nevada, United States
• Delaware Valley Urology, LLC-Voorhees — Voorhees Township, New Jersey, United States
• Memorial Sloan Kettering Cancer Centre — New York, New York, United States
• Hudson Valley Urology — Poughkeepsie, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Triangle Urology Group — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Urology Clinics of North Texas, P.A. — Dallas, Texas, United States
• M.D. Anderson Cancer Center — Houston, Texas, United States
• Urology San Antonio Research, PA — San Antonio, Texas, United States
• Sentara Medical Group - Urology of Virginia, PC — Norfolk, Virginia, United States
• Andreou Research — Surrey, British Columbia, Canada
• Can-Med Clinical Research — Victoria, British Columbia, Canada
• Dr. Steinhoff Clinical Research — Victoria, British Columbia, Canada
• Centre for Applied Urological Research — Kingston, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada

Full record on ClinicalTrials.gov

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