Trial Information

Intravesical Treatment of Superficial Bladder Cancer Characterized on the Basis of the Tumor Markers p53 and pRb

OBJECTIVES:

- 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.