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Sponsored by: |
Bioniche Life Sciences Inc. |
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Information provided by: | Bioniche Life Sciences Inc. |
ClinicalTrials.gov Identifier: | NCT00406068 |
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).
Condition | Intervention | Phase |
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Bladder Neoplasms |
Drug: Mycobacterial cell wall-DNA complex |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 105 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2012 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
The study will be divided into 3 phases: Induction, Maintenance, and Follow-up.
The Induction Phase will cover a period of 6 weeks. During this time, patients will receive 6 weekly intravesical instillations of 8 mg MCC. The patients will be evaluated at month 3, at which time the patients will enter the Maintenance Phase. The Maintenance Phase will last from month 3 to month 24, and during this time, patients will receive weekly MCC instillations for three weeks at months 3, 6, 12, 18, and 24 and evaluations will be performed at months 3, 6, 9, 12, 15, 18, 21 and 24.
At month 3, the patient will be evaluated to assure that the disease is not progressing. Cytology, cystoscopy and biopsies will be performed to obtain adequate staging (if residual tumor persists). If the patient is disease-free, maintenance therapy will be initiated. Patients with non-muscle invasive tumors at month 3 will, at the discretion of the investigator, receive either a second 6-week induction course or a 3-week maintenance course. Patients who show progression to muscle invasive disease will be referred to other treatments.
At month 6 and thereafter at each evaluation visit, patients will be evaluated and managed according to the following results:
The final 36 months of the study is the Follow-up Phase. Evaluations will be performed at months 30, 36, 42, 48, 54 and 60.
Efficacy evaluations will include standard cystoscopy, biopsies and urine cytology. During the Maintenance Phase, standard cystoscopies will be performed at months 3, 6, 9, 12, 15, 18, 21 and 24 for the surveillance of bladder tumors. During the months that instillations will be performed, cystoscopies will be conducted only once at each of these months. During the Follow-up Phase, cystoscopies will be performed at months 30, 36, 42, 48, 54 and 60.
Mandatory bladder biopsies will be done for all patients at month 6.
During the course of the study, biopsies will be taken only if evident or suspicious lesions are seen during cystoscopy or in case of negative cystoscopy but positive cytology.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Zvi Cohen, PhD | 514-697-6636 ext 3386 | Zvi.cohen@bioniche.com |
Contact: Monique Champagne, BPharm, MSc | 514-697-6636 ext 3273 | Monique.champagne@bioniche.com |
Principal Investigator: | Alvaro Morales, MD | Centre for Applied Urological Research, Kingston General Hospital/Queen's University |
Responsible Party: | Bioniche Life Sciences Inc. ( Zvi Cohen, Program Manager ) |
Study ID Numbers: | HIS-0611-0602 |
Study First Received: | December 1, 2006 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00406068 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Bladder neoplasm Intravesical drug administration Neoplasm recurrence, local |
Transitional cell, carcinoma Carcinoma in situ Mycobacterium |
Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Disease Progression Urogenital Neoplasms Urologic Neoplasms Recurrence |
Carcinoma Urologic Diseases Carcinoma in Situ Mycobacterium Infections Neoplasm Recurrence, Local Urinary tract neoplasm Bladder neoplasm |
Neoplasms Neoplasms by Site |