Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-25 @ 4:52 PM
Study NCT ID:
NCT00138203
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2005-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Suberoylanilide Hydroxamic Acid in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077337', 'term': 'Vorinostat'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D006877', 'term': 'Hydroxamic Acids'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amt@medicine.wisc.edu', 'phone': '(608) 262-8158', 'title': 'Dr. Anne Traynor', 'organization': 'University of Wisconsin Carbone Cancer Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the time subjects started therapy until 30 days after they completed therapy', 'eventGroups': [{'id': 'EG000', 'title': 'SAHA', 'description': 'Suberoylanilide Hydroxamic Acid (SAHA)', 'otherNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Pnemonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Endocrine disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders'}], 'seriousEvents': [{'term': 'Thrombosis', 'notes': 'Grade 4, possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'notes': 'Grade 5 event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'notes': 'Grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'notes': 'Grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'notes': 'One subject with grade 4, one subject with grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Dyspnea', 'notes': 'Grade 3, not related to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Per RECIST Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAHA', 'description': 'Suberoylanilide Hydroxamic Acid (SAHA)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from treatment initiation until the end of treatment. The median number of cycles was 3 (range 1-27)', 'description': 'Per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),\\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 14 subjects were evaulated for response. 2 of the total 16 subjects enrolled were not evaluable due to progression after only 1 cycle of treatment.'}, {'type': 'SECONDARY', 'title': 'Time to Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAHA', 'description': 'Suberoylanilide Hydroxamic Acid (SAHA)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '.9', 'upperLimit': '19.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of treatment to progression (average was 3.7 months)', 'description': 'Time to progression per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),\\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who were considered evaluable (received more than one treatment cycle) were included in these results.'}, {'type': 'SECONDARY', 'title': 'Overall Survial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAHA', 'description': 'Suberoylanilide Hydroxamic Acid (SAHA)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment start to time of death', 'description': 'Overall survial of subjects from the start of treatment to the time of death', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were considered evaulable (received more than one treatment cycle) were included in this evaluation'}, {'type': 'SECONDARY', 'title': 'Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAHA', 'description': 'Suberoylanilide Hydroxamic Acid (SAHA), 400mg orally, once daily, in a 21 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of treatment until 30 days from the last dose of treatment', 'description': 'Number of participants experiencing adverse events possibly related to SAHA from first dose of treatment until 30 days from the last dose of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SAHA', 'description': 'Suberoylanilide Hydroxamic Acid (SAHA), 400mg orally, once daily, in a 21 day cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment will occur at all participating sites from August 2005 - June 2007.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SAHA', 'description': 'Suberoylanilide Hydroxamic Acid (SAHA)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.5', 'spread': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-03', 'studyFirstSubmitDate': '2005-08-29', 'resultsFirstSubmitDate': '2013-02-13', 'studyFirstSubmitQcDate': '2005-08-29', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-25', 'studyFirstPostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Per RECIST Criteria', 'timeFrame': 'Time from treatment initiation until the end of treatment. The median number of cycles was 3 (range 1-27)', 'description': 'Per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),\\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.'}], 'secondaryOutcomes': [{'measure': 'Time to Progression', 'timeFrame': 'From start of treatment to progression (average was 3.7 months)', 'description': 'Time to progression per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),\\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.'}, {'measure': 'Overall Survial', 'timeFrame': 'From treatment start to time of death', 'description': 'Overall survial of subjects from the start of treatment to the time of death'}, {'measure': 'Toxicity', 'timeFrame': 'From first dose of treatment until 30 days from the last dose of treatment', 'description': 'Number of participants experiencing adverse events possibly related to SAHA from first dose of treatment until 30 days from the last dose of treatment.'}]}, 'conditionsModule': {'conditions': ['Recurrent Non-small Cell Lung Cancer', 'Stage IIIB Non-small Cell Lung Cancer', 'Stage IV Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate the response of non-small cell lung cancer to SAHA in the second line setting by applying RECIST criteria.\n\nSECONDARY OBJECTIVES:\n\nI. To estimate the time to progression and overall survival in this patient population.\n\nII. To examine the toxicity profile of SAHA.\n\nTERTIARY OBJECTIVES:\n\nI. To evaluate the molecular activity of SAHA by evaluating its effect on histone acetylation, upregulation of target genes, generation of reactive oxygen species, apoptosis and correlation with P53 status.\n\nII. To explore gene expression profiles that predict response to SAHA.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive oral suberoylanilide hydroxamic acid once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed at 1 month and then every 3 months for 1 year or until disease progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed non-small cell lung carcinoma, Stage IV (distant metastases), stage IIIB with malignant pleural effusion, or recurrent disease\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \\>= 20 mm with conventional techniques or as \\>= 10 mm with spiral CT scan\n* Prior therapy: no more than 1 prior cytotoxic chemotherapy regimen for their Stage IIIB/IV or recurrent disease; no previous irradiation to the only area of measurable disease, unless that site had subsequent progression of disease; radiation therapy must be completed at least 3 weeks prior to initiating study drug\n* Stage IV patients with brain metastases are eligible providing the brain metastases are clinically and radiologically stable 4 weeks after treatment with surgery and/or radiation therapy, and they are not taking steroids\n* Life expectancy greater than 3 months\n* ECOG performance status 0 or 1 (Karnofsky \\>= 70%)\n* Patients must have normal organ and marrow function as defined below:\n* Leukocytes \\>= 3,000/mcL\n* Absolute neutrophil count \\>= 1,500/mcL\n* Platelets \\>= 100,000/mcL\n* Total bilirubin within normal institutional limits\n* AST(SGOT)/ALT(SGPT) =\\< 2.5 X institutional upper limit of normal\n* Creatinine within normal institutional limits OR creatinine clearance \\>= 60 mL/min/1.73 m\\^2 for patients with creatinine levels above institutional normal\n* Peripheral neuropathy =\\< grade 1\n* Caution needs to be exercised when using SAHA with medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of SAHA; since grapefruit juice is known to interact with the CYP450 enzymes, it is recommended that patients abstain from consuming grapefruit, grapefruit juice, and other grapefruit containing products during this study\n* The effects of SAHA on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because HDAC inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients should not have taken valproic acid, another histone deacetylase inhibitor, for at least 2 weeks prior to enrollment\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy within 3 weeks prior to entering the study\n* Patients may not be receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SAHA\n* Any other active malignancy in the past 5 years except non-melanoma skin cancers\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SAHA, breastfeeding should be discontinued if the mother is treated with SAHA\n* HIV-positive patients receiving combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with SAHA; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated'}, 'identificationModule': {'nctId': 'NCT00138203', 'briefTitle': 'Suberoylanilide Hydroxamic Acid in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'NCI-2012-03070'}, 'secondaryIdInfos': [{'id': 'NCI-2012-03070', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CO 04510', 'type': 'OTHER', 'domain': 'University of Wisconsin Hospital and Clinics'}, {'id': '6860', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'P30CA014520', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014520', 'type': 'NIH'}, {'id': 'U01CA062491', 'link': 'https://reporter.nih.gov/quickSearch/U01CA062491', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (vorinostat)', 'description': 'Patients receive oral suberoylanilide hydroxamic acid once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: vorinostat', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'vorinostat', 'type': 'DRUG', 'otherNames': ['L-001079038', 'SAHA', 'suberoylanilide hydroxamic acid', 'Zolinza'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (vorinostat)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (vorinostat)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54307-3508', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'St. Vincent Regional Cancer Center CCOP', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '54601', 'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Gundersen Lutheran', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}, {'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW Health Oncology - 1 South Park', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '54221', 'city': 'Manitowoc', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Holy Family Memorial Hospital', 'geoPoint': {'lat': 44.08861, 'lon': -87.65758}}], 'overallOfficials': [{'name': 'Anne Traynor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}