Bladder Cancer Clinical Trial
Official title:
A Phase I Clinical Trial Assessing Intravesical Antisense Oligonucleotide Targeting Heat Shock Protein 27 for the Treatment of Superficial Bladder Cancer
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.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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