A Study for Treatment of Superficial Bladder Cancer Using OGX-427 (NCT00959868) | Clinical Trial Compass
UnknownPhase 1
A Study for Treatment of Superficial Bladder Cancer Using OGX-427
Canada36 participantsStarted 2009-07
Plain-language summary
This is a single centre, open label, phase I dose escalation trial using a modified accelerated titration design. Patients with superficial bladder tumour (Ta or T1) or CIS and candidates for transurethral resection or muscle invasive disease (\>T2) and candidates for radical cystectomy will be enrolled.
OGX-427 will be given neoadjuvantly over 8 days, followed by a transurethral resection (for superficial disease) or radical cystectomy (for muscle invasive disease).
Baseline Hsp27 levels will be determined from pre-treatment cytological samples from bladder washings and tumour biopsies performed prior to therapy.
Post-treatment PK and PD data will be determined from TUR (for Ta, T1 tumours) or radical cystectomy (for T2 tumours) specimens. A recommended phase II dose will be determined from the toxicity, tissue pK, and percentage of Hsp27 knockdown. Effects of treatment on Hsp27 client protein levels and apoptotic index will also be evaluated.
Evaluation during protocol treatment will take place to assess toxicity. Assessments will occur on various visits as per Evaluation Schedule. Adverse event evaluation based on NCI CTCAEv3.0. For quality of life assessment during treatment, the EORTC QLC-BLS24 will be used before first treatment (day 1) and prior to surgery (TURBT or radical cystectomy). The Day 1 QOL assessment will serve as baseline.
After removal from protocol treatment, all subjects will be followed for toxicity related to study drug for 30 days.
After the study, subjects will be followed according to standard of care. Follow-up for tumour recurrence or superficial tumours will be assessed every three months by cystoscopic examination for two years, then every six months for the next two years, and then yearly thereafter.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient age must be \> 18
. Histologic evidence of bladder cancer (superficial or muscle invasive) or
. No intravesical therapies within the previous 6 months
. No evidence of metastatic disease as determined by physical exam, CT scan or chest- x-ray, where indicated.
. ECOG status must be 0, 1, or 2
. Laboratory requirements (within 7 days of treatment):
. Patient must be able to complete the quality of life questionnaires in either English or French
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To define the maximum tolerated dose (MTD) of OGX-427 administered as an intravesical instillation.
Timeframe: One year
2
To define the dose-limiting toxicities (DLTs) of OGX-427 administered as an intravesical instillation.
. Patients with "indeterminate" or "negative" results from biopsy or cytology will be ineligible for the trial.
. Patients taking warfarin or Coumadin anticoagulation therapy or who have a bleeding disorder. NOTE: Patients who require anticoagulation therapy while on study will be removed from study treatment.
. Pregnant or lactating women
. Patients not accessible for follow-up
. Patients with an active urinary tract infection, upper tract urothelial tumors, active infection including tuberculosis, concurrent febrile illness or impaired immune response from any cause
. Patients with contraindication to spinal or general anesthesia required for a transurethral resection or radical cystectomy
. Recent (\<14 days) urethral trauma or inability to perform catheterization or cystoscopy safely
. Patients known to have a serious illness or medical condition that would impair protocol treatment delivery.