Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-22 @ 8:58 PM
Study NCT ID:
NCT00575393
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2007-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006052', 'term': 'Gold Sodium Thiomalate'}, {'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'C002854', 'term': 'alovudine'}, {'id': 'D013058', 'term': 'Mass Spectrometry'}], 'ancestors': [{'id': 'D013870', 'term': 'Thiomalates'}, {'id': 'D008293', 'term': 'Malates'}, {'id': 'D003998', 'term': 'Dicarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D050607', 'term': 'Organogold Compounds'}, {'id': 'D009942', 'term': 'Organometallic Compounds'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2012-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2007-12-15', 'studyFirstSubmitQcDate': '2007-12-15', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose'}, {'measure': 'Toxicity'}, {'measure': 'Biologic activity'}, {'measure': 'Correlate PKCl expression with antitumor effects of gold sodium thiomalate'}, {'measure': 'Correlate toxicity and/or tumor response or activity with pharmacokinetic and pharmacodynamic parameters'}, {'measure': 'Anti-proliferative activity of gold sodium thiomalate by PET scan'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer', 'recurrent non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Gold sodium thiomalate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of gold sodium thiomalate in treating patients with advanced non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To determine the maximum tolerated dose of gold sodium thiomalate in patients with advanced non-small cell lung cancer.\n* To describe the toxicities associated with this treatment.\n* To describe any preliminary evidence of biologic activity.\n* To further assess the correlation between PKCι expression and the antitumor effects of gold sodium thiomalate.\n* To study the association of clinical (toxicity and/or tumor response or activity) with pharmacokinetic/pharmacodynamic parameters.\n* To describe anti-proliferative activity of gold sodium thiomalate through 3-deoxy-3-\\[\\^18F\\]-fluorothymidine positron emission tomography imaging.\n\nOUTLINE: This is a dose-escalation study of gold sodium thiomalate.\n\nPatients receive gold sodium thiomalate intramuscularly on days 1, 8, 15 and 22. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive gold sodium thiomalate once every 4 weeks until a total cumulative dose of 1 gram is delivered.\n\nBlood samples are collected at baseline and prior to therapy in weeks 3, 5, 7, 9, and 11. Samples are analyzed by mass spectometry for pharmacokinetics. Paraffin-embedded tumor tissue samples are analyzed for PKC\\_l expression and antitumor activity. Antiproliferative effects of gold sodium thiomalate are analyzed by 3-deoxy-3-\\[\\^18F\\]-fluorothymidine positron emission tomography imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed advanced non-small cell lung cancer\n* No known standard therapy for disease that is potentially curative or definitely capable of extending life expectancy\n* No symptomatic or worsening CNS metastases despite optimal therapy\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Life expectancy ≥ 12 weeks\n* ANC ≥ 1,500/µL\n* Platelet count ≥ 100,000/µL\n* Total bilirubin ≤ 2 times upper limit of normal (ULN)\n* AST ≤ 3 times ULN (5 times ULN if liver involvement)\n* Creatinine ≤ 1.2 times ULN\n* Hemoglobin ≥ 9.0 g/dL\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Must be willing to provide blood and tissue samples\n* No uncontrolled infection\n* No New York Heart Association class III or IV heart disease\n* No known allergy to gold sodium thiomalate\n\nPRIOR CONCURRENT THERAPY:\n\n* Recovered from acute, reversible effects of prior chemotherapy regardless of interval since last treatment\n* No prior chemotherapy within the past 3 weeks\n* No prior mitomycin C or nitrosoureas within the past 6 weeks\n* No prior immunotherapy within the past 3 weeks\n* No prior biologic therapy within the past 3 weeks\n* No prior radiotherapy within the past 3 weeks\n* No prior radiotherapy to \\> 25% of bone marrow\n* No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (i.e., utilized for a non-FDA-approved indication and in the context of a research investigation)\n* No concurrent prophylactic colony stimulating factors'}, 'identificationModule': {'nctId': 'NCT00575393', 'briefTitle': 'Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'MC0622'}, 'secondaryIdInfos': [{'id': 'MC0622', 'type': 'OTHER', 'domain': 'Mayo Clinic Cancer Center'}, {'id': '06-003532', 'type': 'OTHER', 'domain': 'Mayo Clinic IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gold sodium thiomalate', 'type': 'DRUG'}, {'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'fluorine F 18 fluorothymidine', 'type': 'OTHER'}, {'name': 'mass spectrometry', 'type': 'OTHER'}, {'name': 'pharmacological study', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259-5499', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic - Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Julian Molina, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}