Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT01827618
Status:
COMPLETED
Last Update Posted:
2015-07-02
First Post:
2013-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-30', 'studyFirstSubmitDate': '2013-03-29', 'studyFirstSubmitQcDate': '2013-04-08', 'lastUpdatePostDateStruct': {'date': '2015-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tissue pharmacodynamic (PD) response to TORC1 inhibition', 'timeFrame': '30 days', 'description': 'PD response defined by significant phospho rpS6 Kinase 1 (S6K1) inhibition (comparing post-treatment to baseline).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bladder', 'Cancer', 'Cystectomy', 'Rapamycin'], 'conditions': ['Invasive Bladder Cancer Stage II']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effects of rapamycin directly on bladder tumors and the effects of rapamycin on the immune system of patients with bladder cancer.', 'detailedDescription': 'This is a presurgical clinical trial which aims to understand the biologic activity of TORC1 inhibition and safety in patients with bladder cancer. In this presurgical setting, paired PMBCs and tumor tissue is evaluated before and after exposure to rapamycin to address target specificity, drug delivery, physiologic effects on tumor growth and apoptosis, and correlation of biomarkers with clinical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Have invasive (≥T1) bladder cancer\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n3. In their treating physician's opinion is a good candidate for radical cystectomy\n4. In their treating physician's opinion does not need neoadjuvant chemotherapy prior to cystectomy\n5. Be able to give informed consent\n6. Be age 18 or older\n7. Have adequate marrow function (defined as granulocytes greater than 1,500 cells/mm3 hemoglobin \\>9.5 gm/dl or platelets more than 100,000 cells/mm3).\n8. Have adequate end-organ function (GFR \\>30, bilirubin \\<1.5, SGOT \\< 3x ULN)\n9. Have a life expectancy \\> one year\n10. Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment\n11. Not have received chemotherapy or radiotherapy in the prior 30 days\n\nExclusion Criteria:\n\n1. Immunosuppressed state (e.g. HIV, use of chronic steroids)\n2. Fixed disease (clinical T4)\n3. Active, uncontrolled infections\n4. Hepatic impairment (SGOT \\>3x ULN)\n5. Unhealed wounds\n6. 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."}, 'identificationModule': {'nctId': 'NCT01827618', 'briefTitle': 'Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'An Immunopharmacodynamic Phase 0/I Study of Rapamycin in Patients Undergoing Radical Cystectomy for Bladder Cancer', 'orgStudyIdInfo': {'id': 'HSC20120135H'}, 'secondaryIdInfos': [{'id': 'KL2 TR000118-05/CTSA', 'type': 'OTHER', 'domain': 'NIH/NCRR; UTHSCSA-Institute for Integration'}, {'id': 'KL2TR000118-05', 'link': 'https://reporter.nih.gov/quickSearch/KL2TR000118-05', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapamycin', 'description': 'Rapamycin 3mg orally daily x 4weeks prior to radical cystectomy', 'interventionNames': ['Drug: Rapamycin']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Rapamycin', 'type': 'DRUG', 'otherNames': ['Sirolimus, Rapamune'], 'armGroupLabels': ['Rapamycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Health Science Center San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Robert S Svatek, MD,MSCI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Health Science Center San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Division of Urologic Oncology', 'investigatorFullName': 'Robert Svatek', 'investigatorAffiliation': 'The University of Texas Health Science Center at San Antonio'}}}}