Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT00103220
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2005-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SJG-136 in Treating Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C423343', 'term': "1,1'-((propane-1,3-diyl)dioxy)bis(7-methoxy-2-methylidene-1,2,3,10,11,11a-hexahydro-5H-pyrrolo(2,1-c)(1,4)benzodiazepin-5,11-dione)"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2013-12-10', 'studyFirstSubmitDate': '2005-02-07', 'studyFirstSubmitQcDate': '2005-02-07', 'lastUpdatePostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recommended phase 2 dose of SJG-136', 'timeFrame': 'Day 28', 'description': 'Defined as when ≤1 out of 6 patients achieve dose-limiting toxicity (DLT) at highest dose level below the maximally administered dose.'}]}, 'conditionsModule': {'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'This phase I trial is studying the side effects and best dose of SJG-136 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the toxicities, pharmacokinetic profile and the recommended phase 2 dose of SJG-136 in patients with an advanced solid tumor.\n\nSECONDARY OBJECTIVES:\n\nI. To determine preliminary efficacy data and evaluation of correlative markers of DNA damage and apoptosis in peripheral blood lymphocytes.\n\nOUTLINE: This is an open-label, dose-escalation study.\n\nPatients receive SJG-136 intravenously (IV) over 20 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SJG-136 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed solid tumor\n\n * Advanced disease, defined as metastatic or unresectable disease\n* Measurable indicator lesions\n* Standard curative or palliative measures do not exist or are no longer effective\n* Previously treated CNS metastases allowed provided patient has completed local therapy AND corticosteroids have been discontinued for at least 4 weeks\n* No known leptomeningeal metastases\n* Performance status - ECOG 0-2\n* Performance status - Karnofsky 60-100%\n* More than 3 months\n* WBC ≥ 3,000/mm\\^3\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Bilirubin ≤ 1.0 mg/dL\n* AST and ALT ≤ 2.5 times upper limit of normal\n* Creatinine \\< 1.4 mg/dL\n* No congestive heart failure\n* No recent myocardial infarction\n* No unstable angina\n* No uncontrolled hypertension\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No active infection\n* No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug\n* No other significant medical history, unstable medical condition, or unstable systemic disease that would preclude study participation\n* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas and 8 weeks for UCN-01)\n* At least 4 weeks since prior radiotherapy\n* No prior radiotherapy to ≥ 25% of hematopoietic bone marrow\n* Recovered from all prior therapy\n* At least 4 weeks since prior investigational anticancer drugs\n* No other concurrent investigational agents\n* No concurrent combination antiretroviral therapy for HIV-positive patients'}, 'identificationModule': {'nctId': 'NCT00103220', 'briefTitle': 'SJG-136 in Treating Patients With Advanced Solid Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Study With SJG-136 (NSC #694501) in Patients With an Advanced Solid Tumor', 'orgStudyIdInfo': {'id': 'NCI-2012-01462'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01462', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'MSKCC-04076'}, {'id': 'CDR0000409581'}, {'id': 'NCI-6818'}, {'id': '04-076', 'type': 'OTHER', 'domain': 'Memorial Sloan-Kettering Cancer Center'}, {'id': '6818', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U01CA069856', 'link': 'https://reporter.nih.gov/quickSearch/U01CA069856', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (SJG-136)', 'description': 'Patients receive SJG-136 IV over 20 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: SJG-136']}], 'interventions': [{'name': 'SJG-136', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Treatment (SJG-136)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Naiyer Rizvi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}