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

Phase 2

Completed

• Conditions: Bladder Cancer; High Risk Superficial
• Interventions: Biological: Bacillus Calmette-Guérin (BCG)

• Registration Number: NCT02281383
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-02
• Status Verified: 2022-02
• Primary Completion: 2022-02-24
• Study Completion: 2022-02-24
• Results First Submitted: 2022-10-18
• Results First Submitted QC: 2022-12-01
• Results First Posted: 2022-12-29
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bacillus Calmette-Guérin (BCG)	Bacillus Calmette-Guérin (BCG)	Patients will be treated with an induction course (6 intravesical instillations) of BCG followed by a second induction course (6 intravesical instillations), with a recovery period between the 2 treatment courses.

Primary Outcome Measures

Name	Time	Method
Response Rate	6 months	(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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Recurrence-free Survival After Complete Response	2 years	Progression is defined as the upstaging, from non-muscle invasive to muscle invasive disease, or metastatic disease will be documented as disease progression.

Trial Locations

Locations (4)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States