Clinical study in patients with bladder cancer
- Conditions
- Treatment of patients with recurrent non-muscle invasive bladder cancerMedDRA version: 19.0 Level: PT Classification code 10005005 Term: Bladder cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-005330-58-NL
- Lead Sponsor
- SAKK (Schweizerische Arbeitsgemeinschaft für klinische Krebsforschung)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 39
Disease characteristics:
-Histologically confirmed diagnosis of recurrent NMIBC (urothelial carcinoma) including repeat TURB confirming tumor-free state of the bladder (confirmed by TURB and biopsy) For patients with pure CIS of the bladder no repeat TURB is necessary.
-Negative cytology before start of treatment, except for patients with concomitant CIS.
-Planned treatment starts 2-6 weeks after last TURB
-Pathological grading includes reporting according to WHO 1973 and 2004.
-One previous cycle of intravesical BCG (induction phase with at least 5 instillations ± maintenance) not more than 5 years ago for NMIBC.
-Patients have recurrent high-risk NMIBC for progression (score 7-23), based on the European Organization for Research and Treatment of Cancer scoring system, failing BCG therapy (EAU 2008 definition), for whom radical cystectomy or re-induction with standard BCG is indicated. This includes:
o Patients with high-grade, non-muscle invasive tumor(s) present at both 3 and 6 months after start of the previous cycle of BCG therapy, and
o Any worsening of the disease under BCG treatment, such as a higher number of recurrences, higher tumor category or higher grade, or appearance of CIS, including low grade tumors, in spite of an initial response.
Patient characteristics:
-Patient must give written informed consent before registration.
-Baseline Quality of Life questionnaire has been completed.
-WHO performance status 0-2
-Age 18 - 85 years
-Adequate hematological values: WBC =2.5 x 109/L, platelets = 100 x 109/L
-Adequate hepatic function: total bilirubin = 2 x ULN, AST/ALT = 5 x ULN
-Adequate renal function: eGFR = 30 mL/min/1.73m2, no need for dialysis
-Women are not breastfeeding. Sexually active women must ensure that their partner wears a condom during intercourse. Women with child-bearing potential are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 6 months thereafter. A negative pregnancy test (serum or urine) before inclusion (within 7 days) into the trial is required for all women with child-bearing potential.
Sexually active men must use a condom during intercourse and ensure that his partner practices contraception. Men agree not to father a child during participation in the trial and during 6 months thereafter.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
Disease characteristics:
-Current or previous = T2 urothelial carcinoma (UC) of the urinary bladder
-Concomitant UC of upper urinary tract, prostate or urethra*, small cell carcinoma of the bladder (with or without neuroendocrine differentiation), micropapillary urothelial carcinoma, pure squamous cell carcinoma of the bladder, (UC with squamous differentiation is allowed), pure adenocarcinoma, lympho-vascular invasion (LVI) in the TURB specimen. * If a staged transurethral resection of the prostate (TURP) shows no histological evidence of UC in the deep resection layer of the prostate, the patient can be included.
-Previous or current evidence of UC in a bladder diverticulum
-Evidence of metastatic disease in the (thoraco-)abdominal CT scan at registration
-Bladder surgery or traumatic catheterization or TURB within 2 weeks prior to the expected start of trial treatment
-Administration of systemic cytotoxic agents within the past 3 years or administration of repeated cytostatic/cytotoxic drugs by intravesical instillations after a UC recurrence after the first BCG therapy (during the past 5 years). Exceptions are one immediate intravesical instillation (<24h) of a cytostatic/cytotoxic drug after TURB or repeated cytostatic/cytotoxic drugs by intravesical instillations before the first BCG therapy.
Patient characteristics:
-Stress urinary incontinence >I°, severe urge or urge urinary incontinence preventing the patient to keep the IMP in the bladder for at least 1 hour (anticholinergics and blocked catheter are allowed in order to achieve this criterion)
-Residual urinary bladder volume after micturition (measured by ultrasound of bladder or inserted catheter) is > 150 ml.
-Bladder diverticula or any other anatomical anomalies of the bladder that cannot be assessed by cystoscopy
-Active concomitant malignant conditions except basal cell skin carcinoma and cervical carcinoma in situ. History of malignancy in the last 3 years except previous NMIBC.
-Primary or secondary immunodeficiencies
-Positive HIV test
-Chronic administration (defined as more than 14 consecutive days) of immunosuppressive drugs or other immune modifying drugs within three months before instillation (for corticosteroids, this will mean prednisolone, or equivalent, 10mg/day). Inhaled and topical steroids are allowed.
-Uncontrollable urinary tract infection, macroscopic haematuria, suspicion of bladder perforation, urethral strictures (if interfering with trial procedures)
-Current and past pelvic radiation and brachytherapy
-Active tuberculosis, suspicion of active tuberculosis, other ongoing mycobacterial infection.
-Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last three months, significant arrhythmias, significant QT-prolongation).
-History of anaphylaxis or severe allergic reactions, known allergies to any component of the investigational product, BCG intolerance
-Local and severe allergy (e.g. ulceration, systemic reactions) to PPD test
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method