Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-29 @ 5:40 PM
Study NCT ID:
NCT01174368
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2010-08-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Macrobeads in Subjects With Castration-Resistant Prostate Cancer Resistant to Taxanes (Docetaxel, Cabazitaxel) and Evidence of Disease Progression on Androgen-axis Inhibition and/or Immunotherapy in the Form of Sipuleucel-T
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '212-746-1551', 'title': 'Angelica Nazarian', 'organization': 'The Rogosin Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cancer Macrobeads', 'description': 'Cancer Macrobead placement in abdominal cavity\n\nCancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Diaphoresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cancer Macrobeads', 'description': 'Cancer Macrobead placement in abdominal cavity\n\nCancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram'}], 'timeFrame': '16 months', 'description': 'Data was not collected.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected.'}, {'type': 'SECONDARY', 'title': 'Number of Metastases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cancer Macrobeads', 'description': 'Cancer Macrobead placement in abdominal cavity\n\nCancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram'}], 'timeFrame': '16 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected. No statistical analysis was performed due to the sample size of one patient.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cancer Macrobeads', 'description': 'Cancer Macrobead placement in abdominal cavity\n\nCancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram'}], 'timeFrame': '16 months', 'description': 'No data was collected.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cancer Macrobeads', 'description': 'Cancer Macrobead placement in abdominal cavity\n\nCancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cancer Macrobeads', 'description': 'Cancer Macrobead placement in abdominal cavity\n\nCancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'No analysis was performed due to small sample size. The one baseline participant withdrew voluntarily from the study after first implantation.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-07', 'studyFirstSubmitDate': '2010-08-01', 'resultsFirstSubmitDate': '2018-05-29', 'studyFirstSubmitQcDate': '2010-08-02', 'lastUpdatePostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-16', 'studyFirstPostDateStruct': {'date': '2010-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '16 months', 'description': 'Data was not collected.'}], 'secondaryOutcomes': [{'measure': 'Number of Metastases', 'timeFrame': '16 months'}, {'measure': 'Progression-free Survival', 'timeFrame': '16 months', 'description': 'No data was collected.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a clinical research study of an investigational (FDA IND-BB 10091) treatment of subjects with castration-resistant prostate cancer resistant to Taxanes (docetaxel, cabazitaxel) and evidence of disease progression on androgen-axis inhibition and/or immunotherapy in the form of sipuleucel-T.\n\nThe treatment is being evaluated for its effect on tumor growth. It consists of the placement (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA macrobeads). The cells in the macrobeads produce substances that have been shown to slow or stop the growth of tumors in experimental animals and veterinary patients. It has been tested in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II studies in patients with colorectal, pancreatic or prostate cancers are in progress.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer of prostate\n* Evidence of metastasis\n* Failed available therapies\n* Resolution of any toxic effects of previous therapies\n* Performance status (ECOG PS) 0-2\n* Adequate hematologic, coagulation (INR 2-3max), hepatic and renal function\n* Life expectancy of 12 months\n* Agrees to contraceptive use while on study if sexually active\n* Sign informed consent document\n\nExclusion Criteria:\n\n* Any condition presenting an unacceptably high anesthetic or surgical risk\n* HIV positive\n* Cognitive impairment such as to preclude informed consent\n* Other surgical treatment, chemotherapy and radiation within four weeks of baseline\n* Inadequate hematologic, coagulation (INR \\>3), hepatic, renal function\n* Hepatic blood flow abnormalities and/or large-volume ascites\n* Concurrent cancer of any other type except skin cancer (excluding melanoma)\n* History of allergic reactions to mouse antigens\n* Active infection, congestive heart failure, unstable angina, serious cardiac arrhythmias, psychiatric illness, difficult social situations not permitting reliable participation, active bleeding'}, 'identificationModule': {'nctId': 'NCT01174368', 'briefTitle': 'Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Macrobeads in Subjects With Castration-Resistant Prostate Cancer Resistant to Taxanes (Docetaxel, Cabazitaxel) and Evidence of Disease Progression on Androgen-axis Inhibition and/or Immunotherapy in the Form of Sipuleucel-T', 'organization': {'class': 'OTHER', 'fullName': 'The Rogosin Institute'}, 'officialTitle': 'An Open-Label, Phase II Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Cell-Containing Agarose-Agarose Macrobeads in the Treatment of Subjects With Castration-Resistant Prostate Cancer Resistant to Taxanes (Docetaxel, Cabazitaxel) and Evidence of Disease Progression on Androgen-axis Inhibition and/or Immunotherapy in the Form of Sipuleucel-T', 'orgStudyIdInfo': {'id': '1003010955'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cancer macrobeads', 'description': 'Cancer Macrobead placement in abdominal cavity', 'interventionNames': ['Biological: Cancer Macrobead placement in abdominal cavity']}], 'interventions': [{'name': 'Cancer Macrobead placement in abdominal cavity', 'type': 'BIOLOGICAL', 'description': '8 macrobeads per kilogram', 'armGroupLabels': ['Cancer macrobeads']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Rogosin Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Barry H Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Rogosin Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Rogosin Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}