Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-07 @ 3:17 AM
Study NCT ID:
NCT03298958
Status:
WITHDRAWN
Last Update Posted:
2019-06-12
First Post:
2017-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive 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': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blinded for study staff (investigator) and patient'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'When it is determined that you are eligible for the study, you will be assigned by chance (like flipping a coin) to one of 2 study groups.\n\n* Sirolimus 0.5 mg/day for 2 years or until disease recurrence\n* Placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No funding was received, no subjects were enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-07', 'studyFirstSubmitDate': '2017-09-26', 'studyFirstSubmitQcDate': '2017-09-26', 'lastUpdatePostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test the hypothesis that rapamycin 0.5 mg daily increases recurrence-free survival for patients with non-muscle invasive bladder cancer', 'timeFrame': 'Patients are treated for 2 years or until disease relapse', 'description': 'Recurrence is defined as histologically-proven bladder cancer (stage CIS, Ta, T1 or ≥T2)'}], 'secondaryOutcomes': [{'measure': 'To determine effects of rapamycin on recurrence-free survival (RFS) for subgroup of patients with non-muscle invasive bladder cancer concurrently receiving BCG immune therapy.', 'timeFrame': 'Patients are treated for 2 years or until disease relapse', 'description': 'Recurrence is defined as histologically-proven bladder cancer (stage CIS, Ta, T1 or ≥T2)'}, {'measure': 'To compare the effects of rapamycin on BCG-specific immunity during treatment of non-muscle invasive bladder cancer with maintenance BCG.', 'timeFrame': 'baseline and 6 months after registration', 'description': 'BCG antigen-specific IFN-gamma ELISPOT responses will be measured'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The study is a multi-site Phase 3 double-blinded randomized placebo-controlled trial. Subjects are randomly assigned to receive either a placebo or oral Sirolimus: 0.5 mg daily. All subjects will be treated for 2 years or until disease recurrence. Patients will undergo endoscopic evaluation of the bladder every 3 months for the first 2 years following enrollment and then every 6 months for an additional 2 years on study. Selection of BCG immune therapy is at the discretion of the treating urologist but in general is reserved for high-risk patients. Patients concurrently receiving BCG immune therapy will receive standard BCG therapy including induction (weekly for 6 weeks) and maintenance (weekly for 3 weeks at 3 months, 6 months, and then every 6 months following tumor resection).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or T1) bladder cancer within 60 days prior to enrollment\n* Be able to give informed consent\n* Be age 18 or older\n* Not be in an immunosuppressed state (e.g. HIV, use of chronic steroids)\n* Not have active, uncontrolled infections\n* Not be on agents known to alter rapamycin metabolism significantly\n* Not have a reported history of liver disease (e.g. cirrhosis)\n* Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment except basal cell carcinoma or squamous cell carcinoma of the skin.\n* Not pregnant, or taking effective contraception before rapamycin therapy, during therapy and for 12 weeks after discontinuation of therapy.\n\nExclusion Criteria:\n\n* Have muscle-invasive (≥T2) bladder cancer\n* Unable to give informed consent\n* Age \\< 18\n* Immunosuppressed state (e.g. HIV, use of chronic steroids)\n* Active, uncontrolled infections\n* On agents known to alter rapamycin metabolism significantly\n* Another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)\n* Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy.\n* Individuals with a reported history of liver disease (e.g. cirrhosis)'}, 'identificationModule': {'nctId': 'NCT03298958', 'briefTitle': 'Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer', 'orgStudyIdInfo': {'id': 'HSC20170277H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Oral Tablet', 'description': 'Subject will be randomized to take the Placebo once daily for 2 years or until disease recurrence', 'interventionNames': ['Drug: Placebo Oral Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sirolimus (Rapamycin) 0.5 mg/day for 2 years', 'description': 'Subject will be randomized to take Sirolimus (Rapamycin) 0.5mg once daily for 2 years or until disease recurrence', 'interventionNames': ['Drug: Rapamycin']}], 'interventions': [{'name': 'Rapamycin', 'type': 'DRUG', 'otherNames': ['Sirolimus'], 'description': 'Subject will be randomized to one of the 2 arms', 'armGroupLabels': ['Sirolimus (Rapamycin) 0.5 mg/day for 2 years']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'Subject will be randomized to one of the 2 arms', 'armGroupLabels': ['Placebo Oral Tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}