A Phase I Clinical Trial Assessing Intravesical Antisense Oligonucleotide Targeting Heat Shock Protein 27 for the Treatment of Superficial Bladder Cancer
1. Patient age must be > 18
2. Histologic evidence of bladder cancer (superficial or muscle invasive) or
CIS as evidenced by:
- Patients presenting with superficial tumours and unknown pathological stage will
have in-clinic bladder washings (performed cystoscopically) and biopsy (cup
- Patients with recurrent superficial disease (Ta or T1) and tissue that is
available for baseline studies (i.e. tissue from previous transurethral
resection stored in paraffin blocks) will be eligible for trial without
requiring cytology or biopsy.
- Patients with previously diagnosed T1 tumours and requiring re-resection of
bladder tumour will be eligible if tissue from the original TURBT is
available for baseline studies.
- Patients presenting as muscle invasive (>T2) disease will be eligible if
they are candidates for radical cystectomy and if baseline tissue from
initial resections is available for baseline studies
3. No intravesical therapies within the previous 6 months
4. No evidence of metastatic disease as determined by physical exam, CT scan or chest-
x-ray, where indicated.
5. ECOG status must be 0, 1, or 2
6. Laboratory requirements (within 7 days of treatment):
- negative urine cultures
- Absolute neutrophils count> 1.5 x 109 cells/L, and platelets count> 100 x 109/L,
- Total bilirubin < 1.5 x upper normal limit (ULN), AST and/or ALT < 1.5 x ULN,
alkaline phosphatase < 1.5 x ULN, and serum creatinine < 1.5 x ULN.
- PTT and INR, within normal limits
7. Patient must be able to complete the quality of life questionnaires in either English
8. Patients must provide written informed consent.
1. Patients with "indeterminate" or "negative" results from biopsy or cytology will be
ineligible for the trial.
2. 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.
3. Pregnant or lactating women
4. Patients not accessible for follow-up
5. 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
6. Patients with contraindication to spinal or general anesthesia required for a
transurethral resection or radical cystectomy
7. Recent (<14 days) urethral trauma or inability to perform catheterization or
8. Patients known to have a serious illness or medical condition that would impair
protocol treatment delivery.