Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT00421135
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
2007-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C542790', 'term': 'palifosfamide lysine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-16', 'studyFirstSubmitDate': '2007-01-10', 'studyFirstSubmitQcDate': '2007-01-10', 'lastUpdatePostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'toxicities', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'pharmacokinetics', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Advanced Cancer']}, 'descriptionModule': {'briefSummary': 'The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metastatic and /or unresectable disease state after previous standard chemotherapy'}, 'identificationModule': {'nctId': 'NCT00421135', 'briefTitle': 'A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alaunos Therapeutics'}, 'officialTitle': 'A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer', 'orgStudyIdInfo': {'id': 'IPM1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'description': 'ZIO-201', 'interventionNames': ['Drug: ZIO-201']}], 'interventions': [{'name': 'ZIO-201', 'type': 'DRUG', 'description': 'ZIO-201 as a single dose given once every 21 days. This is a dose escalation arm.', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Jonathan Lewis, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ZIOPHARM Oncology, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alaunos Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jonathan Lewis, MD PhD Chief Medical Officer', 'oldOrganization': 'ZIOPHARM Oncology, Inc'}}}}