AD 32 With or Without BCG After Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer

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. Identifier: NCT00003759
Recruitment Status : Completed
First Posted : July 18, 2003
Last Update Posted : January 31, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known whether AD 32 is more effective with or without BCG after surgery for superficial bladder cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of AD 32 with or without BCG after surgery in treating patients who have newly diagnosed or recurrent superficial bladder cancer.

Condition or disease Intervention/treatment Phase
Bladder Cancer Biological: BCG vaccine Drug: valrubicin Procedure: conventional surgery Phase 2

Detailed Description:


  • Evaluate the efficacy of peri-operative intravesical AD 32 alone or supplemented with BCG in patients with newly diagnosed or recurrent superficial bladder cancer characterized as either high risk or low risk based on the tumor markers p53 and pRb.
  • For low-risk patients, assess the efficacy of peri-operative AD 32 in preventing tumor recurrence.
  • For high-risk patients, assess the efficacy of combined intravesical therapy with AD 32 administered within 8 hours after transurethral resection along with BCG in decreasing the incidence of tumor progression.
  • Evaluate systemic exposure and urine recovery of AD 32 through pharmacokinetic analysis in a subset of patients.

OUTLINE: This is a randomized, open-label study.

All patients undergo complete transurethral resection to remove bladder tumors. AD 32 is administered by catheter into the bladder within 8 hours after surgery. Patients must hold the AD 32 in the bladder for 90 minutes.

After pathological and tumor marker analysis, patients are assigned to the low or high-risk group as defined by their p53 and pRb phenotype.

  • Low risk: Patients with carcinoma in situ receive BCG by catheter into the bladder once weekly for 6 weeks beginning 7-21 days after treatment with AD 32. Patients assigned to the low-risk group who do not have carcinoma in situ receive no further treatment.
  • High-risk: Patients also receive BCG once weekly for 6 weeks and then once weekly for 3 weeks at 3 months, 6 months, and then every 6 months for a total of 3 years after the first BCG treatment.

All patients undergo cystoscopy every 3 months for the first year and then every 6 months for the next 2 years.

PROJECTED ACCRUAL: Approximately 200 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravesical Treatment of Superficial Bladder Cancer Characterized on the Basis of the Tumor Markers p53 and pRb
Study Start Date : November 1998
Actual Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Information from the National Library of Medicine

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


  • Newly diagnosed or recurrent (at least 2 occurrences within 12 months) Ta, multifocal Ta (at least 2 visible tumors), or stage T1 bladder cancer

    • No carcinoma in situ (Tis) only
    • No T2 or greater tumors
  • No evidence of upper tract (ureter or renal pelvic) transitional cell carcinoma based on intravenous pyelogram performed within 4 months of the TURB



  • 18 and over

Performance status:

  • SWOG 0-2

Life expectancy:

  • Not specified


  • WBC greater than 3,500/mm3
  • Platelet count greater than 100,000/mm3


  • Not specified


  • Not specified


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder


Biologic therapy:

  • No concurrent biological response modifiers


  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy


  • No concurrent radiotherapy


  • Not specified

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 identifier (NCT number): NCT00003759

United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Anthra Pharmaceuticals
Study Chair: Colin P. Dinney, MD M.D. Anderson Cancer Center Identifier: NCT00003759     History of Changes
Other Study ID Numbers: CDR0000066883
First Posted: July 18, 2003    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: November 2002

Keywords provided by National Cancer Institute (NCI):
stage 0 bladder cancer
stage I bladder cancer
recurrent bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action