Bladder Cancer Clinical Trial

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

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.

View Eligibility Criteria

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 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 is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT02281383

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 4 Locations for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT02281383

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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