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Sponsored by: |
Anthera Pharmaceuticals |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003759 |
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 | Intervention | Phase |
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Bladder Cancer |
Biological: BCG vaccine Drug: valrubicin Procedure: conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Intravesical Treatment of Superficial Bladder Cancer Characterized on the Basis of the Tumor Markers p53 and pRb |
Study Start Date: | November 1998 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: Approximately 200 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Colin P. Dinney, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000066883, ANTHRA-A9701/ID97-038, MDA-ID-97038 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003759 History of Changes |
Health Authority: | United States: Federal Government |
stage 0 bladder cancer stage I bladder cancer recurrent bladder cancer |
BCG Vaccine Urinary Tract Neoplasm Cystocele Immunologic Factors Valrubicin Urinary Bladder Diseases Urinary Bladder Neoplasms |
Adjuvants, Immunologic Urogenital Neoplasms Urologic Neoplasms Recurrence Urologic Diseases Bladder Neoplasm |
BCG Vaccine Immunologic Factors Antineoplastic Agents Valrubicin Urinary Bladder Diseases Physiological Effects of Drugs Urinary Bladder Neoplasms Adjuvants, Immunologic |
Urogenital Neoplasms Urologic Neoplasms Pharmacologic Actions Neoplasms Neoplasms by Site Urologic Diseases Therapeutic Uses |