Evaluate the Response to 2 Induction Courses (12 Intravesical Instillations) of Bacillus Calmette-Guérin (BCG) for High Risk Superficial Bladder Cancer
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
1 other identifier
interventional
80
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2014
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 30, 2014
CompletedFirst Posted
Study publicly available on registry
November 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2022
CompletedResults Posted
Study results publicly available
December 29, 2022
CompletedFebruary 8, 2023
February 1, 2022
7.4 years
October 30, 2014
October 18, 2022
January 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Percentage of Participants With Recurrence-free Survival After Complete Response
2 years
Study Arms (1)
Bacillus Calmette-Guérin (BCG)
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Harry Herr, MD
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Harry W. Herr, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2014
First Posted
November 3, 2014
Study Start
October 1, 2014
Primary Completion
February 24, 2022
Study Completion
February 24, 2022
Last Updated
February 8, 2023
Results First Posted
December 29, 2022
Record last verified: 2022-02