Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-26 @ 1:14 PM
Study NCT ID:
NCT00003759
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AD 32 With or Without BCG After Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001500', 'term': 'BCG Vaccine'}, {'id': 'C016163', 'term': 'valrubicin'}], 'ancestors': [{'id': 'D032581', 'term': 'Tuberculosis Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-11', 'completionDateStruct': {'date': '2002-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-30', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-07-17', 'lastUpdatePostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-07-18', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage 0 bladder cancer', 'stage I bladder cancer', 'recurrent bladder cancer'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* For low-risk patients, assess the efficacy of peri-operative AD 32 in preventing tumor recurrence.\n* 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.\n* Evaluate systemic exposure and urine recovery of AD 32 through pharmacokinetic analysis in a subset of patients.\n\nOUTLINE: This is a randomized, open-label study.\n\nAll 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.\n\nAfter pathological and tumor marker analysis, patients are assigned to the low or high-risk group as defined by their p53 and pRb phenotype.\n\n* 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.\n* 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.\n\nAll patients undergo cystoscopy every 3 months for the first year and then every 6 months for the next 2 years.\n\nPROJECTED ACCRUAL: Approximately 200 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Newly diagnosed or recurrent (at least 2 occurrences within 12 months) Ta, multifocal Ta (at least 2 visible tumors), or stage T1 bladder cancer\n\n * No carcinoma in situ (Tis) only\n * No T2 or greater tumors\n* No evidence of upper tract (ureter or renal pelvic) transitional cell carcinoma based on intravenous pyelogram performed within 4 months of the TURB\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* SWOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC greater than 3,500/mm3\n* Platelet count greater than 100,000/mm3\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* 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\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent biological response modifiers\n\nChemotherapy:\n\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* No concurrent hormonal therapy\n\nRadiotherapy:\n\n* No concurrent radiotherapy\n\nSurgery:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00003759', 'briefTitle': 'AD 32 With or Without BCG After Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Intravesical Treatment of Superficial Bladder Cancer Characterized on the Basis of the Tumor Markers p53 and pRb', 'orgStudyIdInfo': {'id': 'CDR0000066883'}, 'secondaryIdInfos': [{'id': 'ANTHRA-A9701/ID97-038'}, {'id': 'MDA-ID-97038'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'BCG vaccine', 'type': 'BIOLOGICAL'}, {'name': 'valrubicin', 'type': 'DRUG'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Colin P. Dinney, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anthra Pharmaceuticals', 'class': 'INDUSTRY'}}}}