Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT00582712
Status:
TERMINATED
Last Update Posted:
2019-12-09
First Post:
2007-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Initial Study of Lithium in Patients With Medullary Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018276', 'term': 'Carcinoma, Medullary'}], 'ancestors': [{'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016651', 'term': 'Lithium Carbonate'}], 'ancestors': [{'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D018020', 'term': 'Lithium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalresearch@surgery.wisc.edu', 'phone': '608-265-0540', 'title': 'Director of Clinical Research', 'organization': 'University of Wisconsin Carbone Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected starting on of after Day 0 up to 4 years.', 'description': 'Adverse events (AEs) were reported routinely at scheduled times during the trial. Additionally, some adverse events were reported in an expedited manner for more timely monitoring of patient safety and care. The serum lithium level was checked after 4-5 days of treatment by blood sample prior to daily dose 1 of lithium. If lithium level was outside the 0.8-1.2 mmol/L range, lithium levels were monitored weekly for 4 weeks and monthly after 4 weeks.\n\nAEs grades range from 1 (mild) to 5 (death).', 'eventGroups': [{'id': 'EG000', 'title': 'Lithium Capsules', 'description': 'Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Death', 'notes': 'Death not associated with CTCAE term - Death was unrelated to study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Grade 3 fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Grade 3 speech impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Grade 2 dizziness (vertigo)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lithium Capsules', 'description': 'Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.'}], 'timeFrame': '1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was ever analyzed, resulted, or published on this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lithium Capsules', 'description': 'Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Complicating disease requiring treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study recruited participants from a large cancer research institution in Wisconsin from December 2007 through May 2008.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lithium Capsules', 'description': 'Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 50 years of age', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '50-59 years of age', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '60-69 years of age', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '> 69 years of age', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This study enrolled participants with Medullary Thyroid Cancer (MTC).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Budget/Funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-19', 'studyFirstSubmitDate': '2007-12-19', 'resultsFirstSubmitDate': '2016-10-18', 'studyFirstSubmitQcDate': '2007-12-27', 'lastUpdatePostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-18', 'studyFirstPostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['medullary thyroid cancer', 'lithium'], 'conditions': ['Medullary Thyroid Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://cancer.wisc.edu/', 'label': 'University of Wisconsin Carbone Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'Primary objective is to evaluate the tumor response rate of patients with MTC treated with Lithium carbonate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed MTC with signs of residual/persistent disease based on tumor marker levels and/or radiographic imaging. Pathologic diagnosis must be confirmed at UWCCC. Grading must be confirmed by pathologic review performed at UWCCC.\n* Elevated neuroendocrine markers at least 1 month post -op. In MTC, persistently elevated neuroendocrine markers such as calcitonin and CEA are indicative of persistent disease.\n* Disease progression is not required for this trial\n\n * 4 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration. Subjects will have had standard of care prior to enrollment. Subjects will have had standard of care prior to enrollment (for example it could include total thyroidectomy, central lymph node dissection, and when necessary ipsilateral radical neck dissection but is tailored to the patient).\n * 3 weeks from the completion of radiation therapy to study registration\n* The following laboratory values obtained within 14 days prior to registration:\n\n * Absolute neutrophils count (ANC) ≥ 1000/mm3\n * Platelets ≥ 75,000/mm3\n * Hemoglobin ≥ 8.0 g/dL\n * Total bilirubin greater than or equal to 2.0 X the upper limit of normal (ULN)\n * AST greater than or equal to 3 X ULN or greater than or equal to 5 X ULN if liver metastases are present\n * Creatinine greater than or equal to ULN\n * Serum sodium within normal limits\n* ECOG performance status of 2\n* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.\n* Availability of tissue specimens to be analyzed for pathologic confirmation.\n* Age ≥ 18 years.\n* Women must not be pregnant or lactating due to the deleterious effects of Lithium carbonate on a fetus or small child. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.\n* Women of childbearing potential and sexually active males are required to use an accepted and effective method of contraception.\n* Patients must not have known history of allergic reactions or adverse reactions to Lithium or its derivatives.\n* Patients are not allowed to be on concurrent chemotherapy or radiation therapy.\n\nExclusion Criteria:\n\n* Gastrointestinal tract disease resulting in an inability to take oral medication (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, bowel obstruction, or inability to swallow the tablets).\n* Significant, active cardiac disease\n* Patients must not be taking the following medications: diuretics, ACE inhibitors, NSAIDs (except aspirin or sulindac), neuroleptics, tetracycline, and COX2 inhibitors.\n* Patients with radiographic evidence of disease will be presented the option to undergo a tumor biopsy although this is not mandatory.\n* Patients already taking Lithium for any reason are not allowed on study'}, 'identificationModule': {'nctId': 'NCT00582712', 'briefTitle': 'An Initial Study of Lithium in Patients With Medullary Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'An Initial Study of Lithium in Patients With Medullary Thyroid Cancer', 'orgStudyIdInfo': {'id': 'CO07312'}, 'secondaryIdInfos': [{'id': '2007-0195', 'type': 'OTHER', 'domain': 'Institutional Review Board'}, {'id': 'NCI-2011-00714', 'type': 'REGISTRY', 'domain': 'NCI Trial ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lithium Capsules', 'description': 'Lithium carbonate', 'interventionNames': ['Drug: Lithium carbonate']}], 'interventions': [{'name': 'Lithium carbonate', 'type': 'DRUG', 'description': 'Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.2; Continue until progressive disease/unacceptable toxicity; Evaluate every 4 weeks.', 'armGroupLabels': ['Lithium Capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Uniersity of Wisconsin Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Herbert Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}