Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer
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).
Drug: Mycobacterial cell wall-DNA complex
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- One year disease-free survival rate [ Time Frame: Prospective ] [ Designated as safety issue: No ]
- The 3, 6 and 24 month disease-free survival rate [ Time Frame: Prospective ] [ Designated as safety issue: No ]
- Duration of disease-free survival in all patients [ Time Frame: Prospective ] [ Designated as safety issue: No ]
- Time to progression to muscle invasive disease [ Time Frame: Prospective ] [ Designated as safety issue: No ]
- Overall survival in all patients [ Time Frame: Prospective ] [ Designated as safety issue: No ]
- Rate of overall drug-related adverse events leading to two consecutive treatment delays of one week each or to the discontinuation of treatment. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2006|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Mycobacterial cell wall-DNA complex
Mycobacterial cell wall-DNA complex
Drug: Mycobacterial cell wall-DNA complex
8 mg MCC, intravesical - Induction Phase (6 weekly intravesical instillations) and Maintenance Phase (3 weekly instillations at months 3, 6, 12, 18 and 24).
Other Name: MCC - Urocidin
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:
- Patients who are disease-free will continue on maintenance treatment.
- Patients who are not disease-free (evidence of papillary lesions, CIS or muscle invasive disease) will be withdrawn from further study treatment and will be referred to other therapies at the discretion of the investigator.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406068
Show 31 Study Locations
|Principal Investigator:||Alvaro Morales, MD||Centre for Applied Urological Research, Kingston General Hospital/Queen's University|