Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT00746603
Status:
TERMINATED
Last Update Posted:
2021-03-02
First Post:
2008-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jel9022@med.cornell.edu', 'phone': '212-305-9770', 'title': 'Jennifer Levine, MD', 'organization': 'Weill Cornell Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination due to poor accrual'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Simvastatin', 'description': 'Escalating dose of simvastatin\n\nSimvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks.', 'otherNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Creatine Kinase', 'notes': 'S #1 at CHOP had increased CK:did not meet adverse event criteria. Later admitted to taking Androgel, not a study exclusion criteria but similar to a drug that was. PI at CHOP made decision to remove patient from study. Repeat CK wnl.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'notes': 'S#2 at CHOP developed rash, chose to stop taking medication.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Grade 3 or Greater Muscle Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin', 'description': 'Escalating dose of simvastatin\n\nSimvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks.'}], 'timeFrame': 'Up to 26 weeks', 'description': 'Number of participants experiencing grade 3 or greater muscle toxicity as evaluated by creatinine kinase laboratory tests.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study terminated in 2009 due to poor enrollment. The principal investigator (PI) and study team are no longer at the institution and the PI has confirmed that the data no longer exists. There are no data to report.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Grade 3 or Higher Liver Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin', 'description': 'Escalating dose of simvastatin\n\nSimvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks.'}], 'timeFrame': 'Up to 26 Weeks', 'description': 'Number of participants experiencing grade 3 or higher liver toxicity as determined by liver function laboratory tests.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study terminated in 2009 due to poor enrollment. The principal investigator (PI) and study team are no longer at the institution and the PI has confirmed that the data no longer exists. There are no data to report.'}, {'type': 'PRIMARY', 'title': 'Change in Carotid Intima-media Thickness Test (CIMT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin', 'description': 'Escalating dose of simvastatin\n\nSimvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks.'}], 'timeFrame': 'Up to 26 Weeks', 'description': 'A change in CIMT measurements ( measured in millimeters (mm)) will be performed.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study terminated in 2009 due to poor enrollment. The principal investigator (PI) and study team are no longer at the institution and the PI has confirmed that the data no longer exists. There are no data to report.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Simvastatin', 'description': 'Escalating dose of simvastatin\n\nSimvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'recruitment occurred in the late effects clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Simvastatin', 'description': 'Escalating dose of simvastatin\n\nSimvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', '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': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Poor enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-10', 'studyFirstSubmitDate': '2008-09-02', 'resultsFirstSubmitDate': '2015-07-27', 'studyFirstSubmitQcDate': '2008-09-02', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-10', 'studyFirstPostDateStruct': {'date': '2008-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Grade 3 or Greater Muscle Toxicity', 'timeFrame': 'Up to 26 weeks', 'description': 'Number of participants experiencing grade 3 or greater muscle toxicity as evaluated by creatinine kinase laboratory tests.'}, {'measure': 'Number of Participants Experiencing Grade 3 or Higher Liver Toxicity', 'timeFrame': 'Up to 26 Weeks', 'description': 'Number of participants experiencing grade 3 or higher liver toxicity as determined by liver function laboratory tests.'}, {'measure': 'Change in Carotid Intima-media Thickness Test (CIMT)', 'timeFrame': 'Up to 26 Weeks', 'description': 'A change in CIMT measurements ( measured in millimeters (mm)) will be performed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Carotid Artery Disease']}, 'descriptionModule': {'briefSummary': 'Lay abstract: Study Purpose With contemporary combined modality therapy the expected longterm survival of children and adolescents with Hodgkin\'s disease (HD) is exceedingly high. Thus, the emphasis for future therapeutic interventions must include attention to the late effects of therapy. The development of cardiovascular disease as a late effect of radiation therapy has been well described and documented. Our recent pilot study of child and young adult HD survivors revealed significant subclinical atherosclerosis as evidenced by increased Carotid Artery Intima Media Thickness (CIMT) compared to controls. The higher CIMT values were positively associated with increasing age, total cholesterol, LDLcholesterol and diastolic BP. This finding was present in children and young adults who had received no or low dose radiation suggesting that chemotherapy or the disease process itself contributes to the development of atherosclerosis and risk for cardiovascular disease. Numerous studies have shown HMG CoA reductase inhibitors ("statins") to be effective in reducing the progression of atherosclerosis in adults. These agents have been studied in children and young adults for over a decade.\n\nThe primary aim of this study is:\n\nTo obtain pilot safety data on the use of simvastatin in young adults treated for HD.\n\nThe secondary aims of this study are:\n\nTo obtain pilot data on the effect of simvastatin on subclinical carotid artery atherosclerosis as measured by Carotid Artery IMT in young adults treated for HD.\n\nTo obtain pilot data on the effect of simvastatin on markers of inflammation measured in the serum of young adults treated for HD.\n\nTo obtain pilot data to serve as the basis for the development of a multicenter randomized study for the use of simvastatin in survivors of HD.', 'detailedDescription': 'With contemporary combined modality therapy the expected longterm survival of children and adolescents with Hodgkin\'s disease (HD) is exceedingly high. Thus, the emphasis for future therapeutic interventions must include attention to the late effects of therapy. The development of cardiovascular disease as a late effect of radiation therapy has been well described and documented. Our recent pilot study of child and young adult HD survivors revealed significant subclinical atherosclerosis as evidenced by increased Carotid Artery Intima Media Thickness (CIMT) compared to controls. The higher CIMT values were positively associated with increasing age, total cholesterol, LDLcholesterol and diastolic BP. This finding was present in children and young adults who had received no or low dose radiation suggesting that chemotherapy or the disease process itself contributes to the development of atherosclerosis and risk for cardiovascular disease. Numerous studies have shown HMG CoA reductase inhibitors ("statins") to be effective in reducing the progression of atherosclerosis in adults. These agents have been studied in children and young adults for over a decade.\n\nThe primary aim of this study is:\n\nTo obtain pilot safety data on the use of simvastatin in young adults treated for HD.\n\nThe secondary aims of this study are:\n\nTo obtain pilot data on the effect of simvastatin on subclinical carotid artery atherosclerosis as measured by Carotid Artery IMT in young adults treated for HD.\n\nTo obtain pilot data on the effect of simvastatin on markers of inflammation measured in the serum of young adults treated for HD.\n\nTo obtain pilot data to serve as the basis for the development of a multicenter randomized study for the use of simvastatin in survivors of HD.\n\nWe will do this by enrolling patients diagnosed with HD and evaluating the safety of simvastatin as evidenced by laboratory measures'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least three years from completion of treatment for Hodgkin's Disease\n* Age 18- 35\n* Ability to complete self report questionnaires in either English or Spanish\n* Willingness of patient, or parent/guardian if patient less than 18 years of age to sign consent to participate in study\n* Willingness of patient to sign assent if greater than 7 years of age and less than 18 years\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* Tanner Stage 1\n* Currently taking cyclosporine, niacin, antiretrovirals, macrolide antibiotic, azole antifungal\n* Liver enzymes greater than 1.5 times the upper level of normal\n* Creatine Kinase greater than 2 times the upper level of normal\n* Use of estrogen containing contraceptive"}, 'identificationModule': {'nctId': 'NCT00746603', 'briefTitle': "Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors", 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': "A Feasibility Study to Evaluate the Safety of Simvastatin in Young Adults Treated for Hodgkin's Disease", 'orgStudyIdInfo': {'id': 'AAAB4447'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A Intervention Arm', 'description': 'Escalating dose of simvastatin in subjects who are survivors of Hodgkin Lymphoma', 'interventionNames': ['Drug: Simvastatin']}], 'interventions': [{'name': 'Simvastatin', 'type': 'DRUG', 'otherNames': ['Zocor'], 'description': 'All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks.', 'armGroupLabels': ['A Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Univeristy Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jennifer Levine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia Univeristy Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}