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A Phase I Clinical Trial Assessing Intravesical Antisense Oligonucleotide Targeting Heat Shock Protein 27 for the Treatment of Superficial Bladder Cancer

Phase 1
18 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

A Phase I Clinical Trial Assessing Intravesical Antisense Oligonucleotide Targeting Heat Shock Protein 27 for the Treatment of Superficial Bladder Cancer

Inclusion Criteria:

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
or French

8. Patients must provide written informed consent.

Exclusion Criteria:

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
cystoscopy safely

8. Patients known to have a serious illness or medical condition that would impair
protocol treatment delivery.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To define the maximum tolerated dose (MTD) of OGX-427 administered as an intravesical instillation.

Outcome Description:

The study medication will be escalated according to a fixed dose escalation plan. Three subjects will be treated per cohort. If one of the three subjects experiences a DLT, three additional subjects will be treated at that dose level (i.e. maximum of 6 subjects per cohort)

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Alan I So, MD, FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vancouver Coastal Health


Canada: Health Canada

Study ID:




Start Date:

July 2009

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Bladder cancer
  • Superficial bladder cancer (Ta or T1)
  • Muscle invasive bladder cancer (T2)
  • Transurethral resection
  • Radical cystectomy
  • OGX-427
  • Antisense oligonucleotide
  • Heat shock protein 27
  • superficial bladder tumour (Ta or T1) or CIS prior to a transurethral resection
  • Muscle invasive (T2) bladder cancer prior to radical cystectomy
  • Urinary Bladder Neoplasms