Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC), Unresponsive to Bacillus-Calmette-Guerin (BCG)
- Conditions
- on Muscular Invasive Bladder Cancer
- Registration Number
- JPRN-jRCT2043210017
- Lead Sponsor
- Shimizu Yoshitaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
-Have pathologically confirmed World Health Organization (WHO) grading system employed for tumor grading) high-risk NMIBC unresponsive to prior BCG therapy defined as:
Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy
-Received prior adequate BCG therapy as defined as at least one of the following (5+2 minimum exposure):
1.At least five of six to eight doses of an initial induction course (adequate induction) plus at least two of three doses of maintenance therapy, OR
2.At least five of six doses of an initial induction course (adequate induction) plus at least two of six doses of a second induction course.
-Ineligible for radical cystectomy or refusal of radical cystectomy
-Adequate organ function
-Muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer
-Has known upper tract or prostatic urethra malignancy
-Has systemic anti-cancer therapy, including investigational agents, within 4 weeks of Baseline
-Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior organ transplant
-Prior treatment with adenovirus-based cancer therapy
-Clinically significant or active cardiac disease
-Active autoimmune disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method