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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

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ClinicalTrials.gov Identifier: NCT02281383
Recruitment Status : Active, not recruiting
First Posted : November 2, 2014
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bladder Cancer High Risk Superficial Biological: Bacillus Calmette-Guérin (BCG) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2014
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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)



Primary Outcome Measures :
  1. response rate [ Time Frame: 1 year ]
    (by cystoscopy and cytology)


Secondary Outcome Measures :
  1. proportion of patients who progress to muscle invasive [ Time Frame: 6 months after BCG ]
    Progression is defined as the upstaging, from non-muscle invasive to muscle invasive disease, or metastatic disease will be documented as disease progression.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281383


Locations
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United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
United States, New York
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Harry W. Herr, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02281383    
Other Study ID Numbers: 14-174
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021
Keywords provided by Memorial Sloan Kettering Cancer Center:
Bacillus Calmette-Guérin (BCG)
14-174
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs