Evaluate the Response to 2 Induction Courses (12 Intravesical Instillations) of Bacillus Calmette-Guérin (BCG) for High Risk Superficial Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Phase II Study to Evaluate the Response to 2 Induction Courses (12 Intravesical Instillations) of Bacillus Calmette-Guérin (BCG) for High Risk Superficial Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02281383
• Other study ID #: 14-174
• Status: Completed
• Phase: Phase 2
• Start date: October 2014
• Est. completion date: February 24, 2022

Study information

• Verified date: February 2022
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase II study. This means that BCG therapy has already been found to be safe in humans. The investigators just want to see if using more treatments works better.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 24, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have high risk non-muscle invasive urothelial bladder carcinoma (Tis, TaHG, or T1) that is pathologically confirmed by the Memorial Sloan Kettering Department of Pathology or a documented history of TaHG or T1 non-muscle invasive urothelial bladder tumors.
• 18 years and older
• All visible papillary lesions must be macroscopically resected within 60 days of treatment initiation.
• Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or biopsy) preferably within 12 months from the start of treatment. Should the imaging or biopsy be performed outside this window it will be up to the physicians discretion to re-scan/biopsy.
• Patients who have received a single dose of mitomycin C following staging TUR.

Exclusion Criteria:

• Currently being treated or scheduled to have radiation treatment for bladder cancer during the study.
• Treatment with intravesical BCG or chemotherapy for a patient's current <T2 tumor during the 12 months prior to the current diagnosis.
• Currently being treated or scheduled to have treatment with any systemic or intravesical chemotherapeutic agent during the study.
• Currently being treated with or having been treated in the last 12 months with any investigational drug for high risk superficial bladder cancer.
• Previous muscle-invasive (i.e., stage T2 or higher) transitional cell carcinoma of the bladder.
• Currently being treated for metastatic transitional cell carcinoma.
• Scheduled to have surgery for bladder cancer during the study.
• Presence of clinically significant infections or congenital or acquired immunodeficiency.

Related Conditions & MeSH terms

• Bladder Cancer
• High Risk Superficial
• Urinary Bladder Neoplasms

Intervention

Biological:
• Bacillus Calmette-Guérin (BCG)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	(by cystoscopy and cytology) Participants who have a response are those who have no evidence of disease in their bladder by both urine cytology and cystoscopy. Participants whose disease remains at the same stage or is downstaged without complete resolution are considered nonresponders and will be documented as having recurred. Participants with worsening tumor, defined as the upstaging from non-muscle invasive to muscle invasive disease, or metastatic disease will be documented as disease progression.	6 months
Secondary	Percentage of Participants With Recurrence-free Survival After Complete Response	Progression is defined as the upstaging, from non-muscle invasive to muscle invasive disease, or metastatic disease will be documented as disease progression.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center