Nctid:
NCT00001504
Payload:
{"FullStudy"=>{"Rank"=>474174, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000001943", "ConditionMeshTerm"=>"Breast Neoplasms"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000009371", "ConditionAncestorTerm"=>"Neoplasms by Site"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000001941", "ConditionAncestorTerm"=>"Breast Diseases"}, {"ConditionAncestorId"=>"D000012871", "ConditionAncestorTerm"=>"Skin Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M4910", "ConditionBrowseLeafName"=>"Breast Neoplasms", "ConditionBrowseLeafAsFound"=>"Breast Cancer", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4908", "ConditionBrowseLeafName"=>"Breast Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15364", "ConditionBrowseLeafName"=>"Skin Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Skin and Connective Tissue Diseases", "ConditionBrowseBranchAbbrev"=>"BC17"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000014212", "InterventionMeshTerm"=>"Tretinoin"}, {"InterventionMeshId"=>"D000077556", "InterventionMeshTerm"=>"Alitretinoin"}, {"InterventionMeshId"=>"D000015474", "InterventionMeshTerm"=>"Isotretinoin"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000007641", "InterventionAncestorTerm"=>"Keratolytic Agents"}, {"InterventionAncestorId"=>"D000003879", "InterventionAncestorTerm"=>"Dermatologic Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M16655", "InterventionBrowseLeafName"=>"Tretinoin", "InterventionBrowseLeafAsFound"=>"Methylprednisolone", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M16093", "InterventionBrowseLeafName"=>"Tamoxifen", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17821", "InterventionBrowseLeafName"=>"Isotretinoin", "InterventionBrowseLeafAsFound"=>"Contrast agent", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M1834", "InterventionBrowseLeafName"=>"Alitretinoin", "InterventionBrowseLeafAsFound"=>"AXS-05", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M10357", "InterventionBrowseLeafName"=>"Keratolytic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M6764", "InterventionBrowseLeafName"=>"Dermatologic Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"Dermatologic Agents", "InterventionBrowseBranchAbbrev"=>"Derm"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Bone Density Conservation Agents", "InterventionBrowseBranchAbbrev"=>"BDCA"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"18"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"May 1996"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"January 2002", "CompletionDateStruct"=>{"CompletionDate"=>"January 2002"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Retinoids", "Biomarkers"]}, "ConditionList"=>{"Condition"=>["Breast Cancer", "Breast Neoplasm"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"3666278", "ReferenceType"=>"background", "ReferenceCitation"=>"Fontana JA. Interaction of retinoids and tamoxifen on the inhibition of human mammary carcinoma cell proliferation. Exp Cell Biol. 1987;55(3):136-44. doi: 10.1159/000163409."}, {"ReferencePMID"=>"6401220", "ReferenceType"=>"background", "ReferenceCitation"=>"Welsch CW, DeHoog JV. Retinoid feeding, hormone inhibition, and/or immune stimulation and the genesis of carcinogen-induced rat mammary carcinomas. Cancer Res. 1983 Feb;43(2):585-91."}, {"ReferencePMID"=>"2292243", "ReferenceType"=>"background", "ReferenceCitation"=>"Jordan VC, Murphy CS. Endocrine pharmacology of antiestrogens as antitumor agents. Endocr Rev. 1990 Nov;11(4):578-610. doi: 10.1210/edrv-11-4-578. No abstract available."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Patients continue treatment for up to 28 weeks, with tamoxifen continued after the study if medically appropriate.", "DetailedDescription"=>"This is a Phase I study of the combination tamoxifen and 9-cis-Retinoic acid in patients with breast cancer. The primary objective of the study is; 1) to determine the maximum tolerated dose of 9-cis-Retinoic acid in combination with Tamoxifen and to determine the overall and dose limiting toxicities. Other objectives are: 2) to determine the effect of Tamoxifen on the pharmacokinetics of 9-cis-Retinoic acid; 3) to evaluate the anti-tumor activity of this combination therapy within the context of a phase I study; 4) and to determine the expression of surrogate biomarkers of breast carcinogenesis before and after treatment."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nAll patients must have histologically documented diagnosis of Stage III, or IV breast carcinoma.\n\nPatients with stage III that has completed chemotherapy: Estrogen receptor (ER) or progesterone receptor (PR) positive tumor required if premenopausal. Either ER/PR-positive or -negative tumor allowed if postmenopausal and have received prior chemotherapy.\n\nPatients may have stage IV with ER/PR-positive or -negative tumor.\n\nNo CNS metastases, pseudotumor cereri, or seizures.\n\nPRIOR/CONCURRENT THERAPY:\n\nPatients who have ecovered from the toxic effects of prior therapy will be eligible.\n\nPatients with prior tamoxifen will be allowed to participate. At least 3 weeks must have elapsed since the last dose of chemotherapy.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nSex: Men and women.\n\nMenopausal status: Any status.\n\nPatients must have a performance status of ECOG 0-2.\n\nPatients must have Hematopoietic criteria of:\n\nANC at least 1,500/mm(3).\n\nPlatelet count at least 90,000/mm(3).\n\nPatients must have Hepatic criteria of:\n\nIn the absence of tumor involvement:\n\nBilirubin no greater than twice normal;\n\nSGOT no greater than twice normal;\n\nAlkaline phosphate no greater than twice normal;\n\nFasting triglycerides less than 3 times normal.\n\nPatients must have Renal criteria of:\n\nSerum creatinine no greater than 1.5 mg/dL OR;\n\nCreatinine clearance at least 60 mL/min.\n\nOther:\n\nNo allergy to study medications.\n\nNo nonmalignant systemic disease that would preclude therapy.\n\nNo second malignancy within 5 years except: Curatively treated basal cell skin carcinoma. Cervical carcinoma in situ.\n\nPregnant women will be excluded.\n\nNegative pregnancy test required within 7 days prior to entry.\n\nAdequate contraception required for 4 weeks prior to, during, and for 1 year after study.\n\nPatients must give informed consent.\n\nPatients who are poor medical or psychiatric risks will be eligible."}, "IdentificationModule"=>{"NCTId"=>"NCT00001504", "BriefTitle"=>"A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients", "OrgStudyIdInfo"=>{"OrgStudyId"=>"960080"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"96-C-0080"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"9-cis-Retinoic Acid", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Cancer Institute (NCI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Cancer Institute (NCI)", "LeadSponsorClass"=>"NIH"}}}}}}