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A Study for Treatment of Superficial Bladder Cancer Using OGX-427

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00959868
Recruitment Status : Unknown
Verified February 2012 by Vancouver Coastal Health.
Recruitment status was:  Recruiting
First Posted : August 17, 2009
Last Update Posted : February 13, 2012
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: OGX-427 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial Assessing Intravesical Antisense Oligonucleotide Targeting Heat Shock Protein 27 for the Treatment of Superficial Bladder Cancer
Study Start Date : July 2009
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: OGX-427
    OGX-427 drug product is in 25mg/mL injection in a mannitol-phosphate buffer solution packaged to deliver at least 8mL volume from a 10mL Type I, clear glass vial (ammonium sulfate treated) with Teflon coated bromobutyl rubber stopper and sealed with an aluminum, red, flip-off over seal. The drug product is aseptically compounded and sterilized via sterile filtration prior to aseptic filling.

Outcome Measures

Primary Outcome Measures :
  1. To define the maximum tolerated dose (MTD) of OGX-427 administered as an intravesical instillation. [ Time Frame: One year ]
    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)

  2. To define the dose-limiting toxicities (DLTs) of OGX-427 administered as an intravesical instillation. [ Time Frame: one year ]
    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)

Secondary Outcome Measures :
  1. To determine the toxicity profile of OGX-427 when administered intravesically. [ Time Frame: One year ]
  2. To measure evidence of OGX-427 effect on expression of Hsp27. [ Time Frame: one year ]
  3. To determine the bladder PK and PD profile of OGX-427 after intravesical administration. [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 biopsy).
    • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959868

Contact: Maureen Palmer, RN 604-875-5675 Maureen.Palmer@vch.ca

Canada, British Columbia
The Prostate Centre at Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Maureen Palmer, RN    604-875-5675    Maureen.Palmer@vch.ca   
Principal Investigator: Alan I So, MD, FRCSC         
Sub-Investigator: Peter C Black, MD, FRCSC         
Sub-Investigator: Edward C Jones, MD, FRCPC, LMCC         
Sponsors and Collaborators
Vancouver Coastal Health
NCIC Clinical Trials Group
Vancouver General Hospital Foundation
Principal Investigator: Alan I So, MD, FRCSC Vancouver Coastal Health
More Information

Responsible Party: Alan I. So, MD, FRCSC, Vancouver Coastal Health
ClinicalTrials.gov Identifier: NCT00959868     History of Changes
Other Study ID Numbers: BL-01
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: February 2012

Keywords provided by Vancouver Coastal Health:
Bladder cancer
Superficial bladder cancer (Ta or T1)
Muscle invasive bladder cancer (T2)
Transurethral resection
Radical cystectomy
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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases