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


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

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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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- SWOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC greater than 3,500/mm3

- Platelet count greater than 100,000/mm3

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent biological response modifiers

Chemotherapy:

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy

Radiotherapy:

- No concurrent radiotherapy

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Colin P. Dinney, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066883

NCT ID:

NCT00003759

Start Date:

November 1998

Completion Date:

November 2002

Related Keywords:

  • Bladder Cancer
  • stage 0 bladder cancer
  • stage I bladder cancer
  • recurrent bladder cancer
  • Urinary Bladder Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009