Initial or recurrent superficial bladder cancer that cannot be completely resected and carcinoma in situ (CIS) of the bladder.
Conditions
Interventions
Freeze-dried BCG for intravesical use (Japanese strain) (Immunobladder for intravesical instillation 80 mg/40 mL) will be instilled 8 times.
Freeze-dried BCG for intravesical use (Japanese strain) (Im
Sponsors
Study Group for Low-dose BCG Intravesical Instillation Therapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed transitional cell carcinoma. 2) Confirmed superficial bladder cancer that cannot be completely resected or carcinoma in situ (CIS) of the bladder. CIS may be primary, secondary or concurrent. In patients with concurrent CIS however, coexisting bladder cancer must be only superficial and have been completely resected. *Note: Patients with concurrent CIS who have received radical TURBT will be excluded from this study although biopsy is required. Patients with concurrent CIS who have had coexisting superficial bladder cancer resected at least twice to complete elimination will be excluded from this study because the start of treatment of concurrent CIS may be complicated. 3) Performance status of 0 to 2. 4) Patients that can receive assessment, such as cystoscopy and urinary cytology on a regular basis. 5) Male or female, aged between 20 and 85 years. 6) Intact function of the main organs Hb>=10 g/dL; PLT>=10&#61620;104/mm3; WBC>=3,000/mm3; AST (GOT), ALT (GPT), ALP<normal value&#61620;2, serum creatinine<=1.5 mg/dL. 7) Patients that have given written informed consent prior to the start of this study.
Exclusion criteria
Exclusion criteria: 1)Active tuberculous lesion or strongly positive tuberculin reaction*. *: Strongly positive tuberculin reaction is defined as redness with a maximum diameter of >= 10 mm accompanied by induration with redness, blister, and necrosis. 2) Active double cancer (including upper urinary tract carcinoma and prostatic urethral cancer) 3) Previously received BCG intravesical instillation therapy 4) History of upper urinary tract carcinoma 5) Previously received systemic intravenous or intra-arterial infusion of an anti-cancer drug or radiation therapy for bladder cancer 6) Previously received TURBT, systemic chemotherapy or intravesical instillation therapy with an anti-cancer drug within 4 weeks prior to biopsy 7) Contracted bladder 8) Serious drug hypersensitivity 9) Previously received local radiation therapy for the bladder 10) Patients receiving pharmacotherapy, including steroids at an immunosuppressive dose 11) Serious viral or bacterial infection 12) Interstitial pneumonia or pulmonary fibrosis 13) Severe cardiac (circulatory), pulmonary, renal, hepatic, or hematopoietic impairment 14) Other serious complications 15) Pregnant or possibly pregnant women 16) Patients the investigator considers to be inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate (CR rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Relapse-free survival (all secondarily enrolled subjects/subjects with CR) 2) Incidence of adverse drug reactions 3) Progression-free survival 4) Achievement rate for instillation frequency 5) Overall survival rate 6) QOL | — |
Countries
Japan
Contacts
Public ContactAkira Yokomizo
Graduate School of Medical Sciences, Kyushu University Department of Urology
Outcome results
None listed