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BRIEF TITLE: 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


  • Org Study ID: 14-174
  • Secondary ID:
  • NCT ID: NCT02281383
  • NCT Alias:
  • Sponsor: Memorial Sloan Kettering Cancer Center - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting October 2014 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: response rate

Primary Outcome 1 - Time Frame: 1 year

Condition:

  • Bladder Cancer
  • High Risk Superficial

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 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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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Harry W. Herr, MD

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Harry W. Herr, MD

Phone: 646-422-4411

Email:

Link: Memorial Sloan Kettering Cancer Center

Locations

Facility Status Contact
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
United States
Recruiting Harry Herr, MD
646-422-4411
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United States
Recruiting Harry Herr, MD
646-422-4411
Memorial Sloan Kettering Commack
Commack, New York 11725
United States
Recruiting Harry Herr, MD
646-422-4411
Memorial Sloan Kettering Westchester
Harrison, New York 10604
United States
Recruiting Harry Herr, MD
646-422-4411
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Recruiting Harry W. Herr, MD
646-422-4411