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

January 12, 2023 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Memorial Sloan Kettering Cancer Center
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Biological: Bacillus Calmette-Guérin (BCG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Recurrence-free Survival After Complete Response
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2014

Primary Completion (ACTUAL)

February 24, 2022

Study Completion (ACTUAL)

February 24, 2022

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

October 31, 2014

First Posted (ESTIMATE)

November 2, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-174

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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