Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-04-12 @ 8:53 AM
Study NCT ID:
NCT00525135
Status:
TERMINATED
Last Update Posted:
2015-02-03
First Post:
2007-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014635', 'term': 'Valproic Acid'}], 'ancestors': [{'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Elaine.Cooperstein@ucsf.edu', 'phone': '415-502-3212', 'title': 'UCSF PRS Administrator', 'organization': 'University of California San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '17 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Study Intervention', 'description': 'Patients receive valproic acid daily for 16 weeks.', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Decrease in Thyroglobulin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Intervention', 'description': 'Patients receive valproic acid daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 16 weeks', 'description': 'Number of participants with decreased thyroglobulin level after study treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Increased Radioactive Iodine Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Intervention', 'description': 'Patients receive valproic acid daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 10 weeks', 'description': 'Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects of Drugs Affecting Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Intervention', 'description': 'Patients receive valproic acid daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '17 weeks', 'description': 'Number of participants experiencing \\> Grade 1 adverse events (including fatigue) attributable to study treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Decrease in Tumor Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Intervention', 'description': 'Patients receive valproic acid daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 16 weeks', 'description': 'Number of participants with decreased tumor size after study treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Intervention', 'description': 'Patients receive valproic acid daily for 16 weeks.'}], 'timeFrame': 'up to 10 years post-study treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination, participants were not followed for survival after the primary outcome timeframe'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Intervention', 'description': 'Patients receive valproic acid daily for 16 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Intervention', 'description': 'Patients receive valproic acid daily for 16 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Due to a registration error, the PI did not receive notifications to report results until after the data retention period had passed; numeric data are no longer available for analysis.', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': 'NA', 'comment': 'Due to a registration error, the PI did not receive notifications to report results until after the data retention period had passed; numeric data are no longer available for analysis.', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': 'NA', 'comment': 'Due to a registration error, the PI did not receive notifications to report results until after the data retention period had passed; numeric data are no longer available for analysis.', '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'PI left university and study was halted prematurely. No data was analyzed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-21', 'studyFirstSubmitDate': '2007-08-28', 'resultsFirstSubmitDate': '2015-01-21', 'studyFirstSubmitQcDate': '2007-09-04', 'lastUpdatePostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-21', 'studyFirstPostDateStruct': {'date': '2007-09-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in Thyroglobulin Level', 'timeFrame': 'Baseline, 16 weeks', 'description': 'Number of participants with decreased thyroglobulin level after study treatment'}, {'measure': 'Decrease in Tumor Size', 'timeFrame': 'Baseline, 16 weeks', 'description': 'Number of participants with decreased tumor size after study treatment'}], 'secondaryOutcomes': [{'measure': 'Increased Radioactive Iodine Uptake', 'timeFrame': 'Baseline, 10 weeks', 'description': 'Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy'}, {'measure': 'Side Effects of Drugs Affecting Quality of Life', 'timeFrame': '17 weeks', 'description': 'Number of participants experiencing \\> Grade 1 adverse events (including fatigue) attributable to study treatment'}, {'measure': 'Survival', 'timeFrame': 'up to 10 years post-study treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs such as valproic acid may make thyroid cancers more radioiodine sensitive, which will allow for detection of tumor and make further ablation treatment effective.', 'detailedDescription': 'PURPOSE: This phase II trial is studying how well valproic acid works in treating patients with thyroid cancers that do not respond well to other treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\nDISEASE CHARACTERISTICS\n\n* Diagnosis of advanced/poorly differentiated thyroid cancer of follicular cell origin that is radioiodine-unresponsive\n* Cumulative dose of radioiodine \\< 800 mCi\n* No radioiodine uptake on whole body scan within 18 months of enrollment\n* Inoperable extensive locoregional tumor mass and/or metastatic spread\n* Failed conventional therapy that included total thyroidectomy AND radioactive iodine I 131 ablation\n* Elevated thyroglobulin level (\\>2ng/ml on thyroid hormone, \\>10ng/ml off thyroid hormone)or Tg-antibody positive\n\nPATIENT CHARACTERISTICS\n\n-18 years or older\n\nEntry lab results:\n\n* Hemoglobin \\> 8.0 gm/dl\n* Absolute Neutrophil Count \\> 750 cells/mm3\n* Platelet count \\> 75000/mm3\n* BUN \\< 1.5 times upper limit of normal (ULN)\n* Creatinine \\< 1.5 times ULN\n* Total protein \\> 6.4\n* Total bilirubin should be \\< 1.5 times ULN.\n* AST (SGOT), ALT (SGPT), ALKP and amylase \\< 1.5 times ULN\n* Amylase \\< 1.5 times ULN\n* Albumin \\> 2.5\n* Ammonia \\< 1.5 times ULN\n\nEXCLUSION CRITERIA:\n\n* Not pregnant\n* No nursing within the past 3 months\n* No allergy to valproic acid\n* No coexisting malignancy other than basal cell carcinoma\n* No hepatic disease or significant dysfunction\n* Karnofsky score \\> 80\n* No pancreatitis\n* No kidney dysfunction\n* Fertile patients must use effective contraception'}, 'identificationModule': {'nctId': 'NCT00525135', 'briefTitle': 'Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'A Phase II Trial of Valproic Acid (Depakote ER ®) in Patients With Advanced Thyroid Cancers of Follicular Origin, Who Are Thyroglobulin Positive/RAI Unresponsive', 'orgStudyIdInfo': {'id': 'Valproic Acid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'If a patient exhibits increased radioiodine uptake on the Thyrogen scan post valproic acid therapy, patients will then prepare for ablative treatment and will remain on valproic acid for a total of 16 weeks, until receiving RAI ablation.', 'interventionNames': ['Drug: Valproic Acid']}, {'type': 'OTHER', 'label': '2', 'description': 'If no increased uptake is seen, patients will continue on valproic acid for 6 additional weeks at an increased dosage, totaling an overall treatment time of 16 weeks as well.', 'interventionNames': ['Drug: Valproic Acid']}], 'interventions': [{'name': 'Valproic Acid', 'type': 'DRUG', 'description': 'OUTLINE: This is a pilot study.\n\nPatients receive valproic acid daily for 16 weeks. Dose increases on Days 4 and 8; dose remains the same for weeks 2-10. All patients will undergo a Thyrogen® (thyrotropin alfa for injection) RAI scan at entry to the study and after completion of 10 weeks of valproic acid treatment.\n\nQuality of life is assessed at the end of every week through a study diary.\n\nPatients are followed at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 17 (Schedule 1) weeks. Patients return for follow-up at 3, 6, and 12 months.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Electron Kebebew, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}