Clinical trial NCT02281383: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
High Risk Superficial
Keywords: Bacillus Calmette-Guérin (BCG)
14-174
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-11-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Response Rate
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Participants With Recurrence-free Survival After Complete Response
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Harry W. Herr, MD
role: PRINCIPAL_INVESTIGATOR
References: