Bladder Cancer, High Risk Superficial
Conditions
Keywords
Bacillus Calmette-Guérin (BCG), 14-174
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.
Interventions
BIOLOGICALBacillus Calmette-Guérin (BCG)
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Recurrence-free Survival After Complete Response | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Bacillus Calmette-Guérin (BCG) | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 1 |
| Overall Study | Progressive Disease | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Bacillus Calmette-Guérin (BCG) |
|---|---|
| Age, Continuous | 71 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 70 Participants |
| Region of Enrollment United States | 80 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 80 |
| other Total, other adverse events | 12 / 80 |
| serious Total, serious adverse events | 4 / 80 |
Outcome results
Primary
Response Rate
(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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bacillus Calmette-Guérin (BCG) | Response Rate | Stable Response | 18 Participants |
| Bacillus Calmette-Guérin (BCG) | Response Rate | Complete Response | 62 Participants |
Secondary
Percentage of Participants With Recurrence-free Survival After Complete Response
Progression is defined as the upstaging, from non-muscle invasive to muscle invasive disease, or metastatic disease will be documented as disease progression.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bacillus Calmette-Guérin (BCG) | Percentage of Participants With Recurrence-free Survival After Complete Response | 85 percentage of participants |