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

Primary Purpose

Bladder Cancer, High Risk Superficial

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bacillus Calmette-Guérin (BCG)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Bacillus Calmette-Guérin (BCG), 14-174

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Commack
  • Memorial Sloan Kettering Westchester
  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bacillus Calmette-Guérin (BCG)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 30, 2014
Last Updated
January 12, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02281383
Brief Title
Evaluate the Response to 2 Induction Courses (12 Intravesical Instillations) of Bacillus Calmette-Guérin (BCG) for High Risk Superficial Bladder Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
February 24, 2022 (Actual)
Study Completion Date
February 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, High Risk Superficial
Keywords
Bacillus Calmette-Guérin (BCG), 14-174

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bacillus Calmette-Guérin (BCG)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Bacillus Calmette-Guérin (BCG)
Primary Outcome Measure Information:
Title
Response Rate
Description
(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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With Recurrence-free Survival After Complete Response
Description
Progression is defined as the upstaging, from non-muscle invasive to muscle invasive disease, or metastatic disease will be documented as disease progression.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry W. Herr, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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