Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-03-08 @ 5:55 AM
Study NCT ID:
NCT03034135
Status:
COMPLETED
Last Update Posted:
2021-09-13
First Post:
2017-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000726772', 'term': 'disulfiram-copper'}, {'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smarcus@cantex.com', 'phone': '9543153660', 'title': 'Stephen Marcus MD', 'organization': 'Cantex Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '14 months', 'eventGroups': [{'id': 'EG000', 'title': 'Group A', 'description': 'Eligible patients must have progressed after standard chemoradiotherapy and within 3 months of the last dose of TMZ.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 14, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Hepatobiliary disorders', 'notes': 'Liver enzyme elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Liver'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DSF-Cu', 'description': 'Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.\n\nDisulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.\n\nTemozolomide (TMZ): TMZ is given per standard of care'}], 'classes': [{'title': 'Complete response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DSF-Cu', 'description': 'Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.\n\nDisulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.\n\nTemozolomide (TMZ): TMZ is given per standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Percentage of patients that are free from progressive disease per RANO criteria', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DSF-Cu', 'description': 'Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.\n\nDisulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.\n\nTemozolomide (TMZ): TMZ is given per standard of care'}], 'classes': [{'title': '6 months', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '81'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '54'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months', 'description': 'Percentage of patients that are alive', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DSF-Cu', 'description': 'Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.\n\nDisulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.\n\nTemozolomide (TMZ): TMZ is given per standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 months', 'description': 'Number of Participants with Grade 3 and 4 serious adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DSF-Cu', 'description': 'Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.\n\nDisulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.\n\nTemozolomide (TMZ): TMZ is given per standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '1.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'Duration of progression free survival according to RANO criteria', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Duration of Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DSF-Cu', 'description': 'Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.\n\nDisulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.\n\nTemozolomide (TMZ): TMZ is given per standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '8.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 months', 'description': 'Duration of overall survival for patients that are alive', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DSF-Cu', 'description': 'Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.\n\nDisulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.\n\nTemozolomide (TMZ): TMZ is given per standard of care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Disulfiram and Copper Gluconate', 'description': 'Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.\n\nDisulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.\n\nTemozolomide (TMZ): TMZ is given per standard of care'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000', 'lowerLimit': '43', 'upperLimit': '74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-28', 'size': 1506328, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-16T13:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'dispFirstSubmitDate': '2019-07-23', 'completionDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2017-01-25', 'dispFirstSubmitQcDate': '2021-08-17', 'resultsFirstSubmitDate': '2021-04-02', 'studyFirstSubmitQcDate': '2017-01-26', 'dispFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-17', 'studyFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': '6 months', 'description': 'ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '6 months', 'description': 'Percentage of patients that are free from progressive disease per RANO criteria'}, {'measure': 'Overall Survival', 'timeFrame': '6 months and 12 months', 'description': 'Percentage of patients that are alive'}, {'measure': 'Number of Participants With Serious Adverse Events', 'timeFrame': '14 months', 'description': 'Number of Participants with Grade 3 and 4 serious adverse events'}, {'measure': 'Median Progression Free Survival', 'timeFrame': '12 months', 'description': 'Duration of progression free survival according to RANO criteria'}, {'measure': 'Median Duration of Overall Survival', 'timeFrame': '14 months', 'description': 'Duration of overall survival for patients that are alive'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Glioblastoma']}, 'referencesModule': {'references': [{'pmid': '30771200', 'type': 'DERIVED', 'citation': 'Huang J, Chaudhary R, Cohen AL, Fink K, Goldlust S, Boockvar J, Chinnaiyan P, Wan L, Marcus S, Campian JL. A multicenter phase II study of temozolomide plus disulfiram and copper for recurrent temozolomide-resistant glioblastoma. J Neurooncol. 2019 May;142(3):537-544. doi: 10.1007/s11060-019-03125-y. Epub 2019 Feb 15.'}]}, 'descriptionModule': {'briefSummary': 'This study of DSF-Cu in combination with TMZ for recurrent GBM will evaluate the antitumor effect in patients who have recurrent GBM. Patients will take DSF-Cu daily during their routine standard of care with TMZ therapy for approximately 6 months. Patients will be evaluated for response every 8 weeks. Patients will be followed up 2 years after the last dose of DSF-Cu.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed GBM (WHO grade IV).\n* The subject must have completed RT with concurrent TMZ at least 12 weeks prior to the planned start of treatment on this study UNLESS there is pathological verification of recurrent tumor and at least 4 weeks have elapsed since the end of RT with concurrent TMZ.\n* Experienced first unequivocal progression of tumor by magnetic resonance imaging (MRI) \\[as assessed via Radiologic Assessment in Neuro-Oncology (RANO) criteria within 3 months from the last dose of TMZ.\n* Karnofsky performance status (KPS) of at least 60%.\n* Willing to remain abstinent from consuming alcohol.\n* Recovered from the toxic effects of prior therapy to \\< grade 2 toxicity per NCI CTCAE prior to study registration (except lymphopenia).\n* Meets laboratory criteria for the following parameters: ANC, platelets, hemoglobin, total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, BUN and creatinine.\n* 11\\. Females of childbearing potential must be willing to use an acceptable method of birth control (i.e., intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.\n\nExclusion Criteria:\n\n* Radiographic evidence of leptomeningeal dissemination, gliomatosis cerebri, infratentorial tumor, or disease at sites remote from the supratentorial brain.\n* Enrolled in another clinical trial testing a novel therapy or drug within the past 4 weeks.\n* Received more than one course of radiation therapy or more than a total dose of 75 Gy.\n* History of allergic reaction/hypersensitivity to temozolomide, dacarbazine, DSF or Cu.\n* Treatment with the following medications are contraindicated with DSF: metronidazole, isoniazid, dronabinol, carbocisteine, lopinavir, paraldehyde, ritonavir, sertraline, tindazole, tizanidine, atazanavir.\n* Fever within 3 days prior to study enrollment.\n* Active or severe hepatic or renal disease.\n* Grade 2 or higher peripheral neuropathy or ataxia per NCI CTCAE\n* History of idiopathic seizure disorder schizophrenia, or psychosis unrelated to glioblastoma, corticosteroid, or anti-epileptic medications.\n* History of Wilson's disease.\n* History of hemochromatosis.\n* Pregnant or breastfeeding."}, 'identificationModule': {'nctId': 'NCT03034135', 'briefTitle': 'Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cantex Pharmaceuticals'}, 'officialTitle': 'A Phase II, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Efficacy of DIsulfiram and Copper Gluconate in Recurrent Glioblastoma', 'orgStudyIdInfo': {'id': 'CAN-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DSF-Cu', 'description': 'Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.', 'interventionNames': ['Drug: Disulfiram/Copper', 'Drug: Temozolomide (TMZ)']}], 'interventions': [{'name': 'Disulfiram/Copper', 'type': 'DRUG', 'description': 'Disulfiram/copper gluconate is taken three times a day.', 'armGroupLabels': ['DSF-Cu']}, {'name': 'Temozolomide (TMZ)', 'type': 'DRUG', 'description': 'TMZ is given per standard of care', 'armGroupLabels': ['DSF-Cu']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'John Theurer Cancer Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lenox Hill Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84112-5550', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Jiayi Huang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Washington University School of Medicine in St. Louis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cantex Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}