Nctid:
NCT00002188
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012514", "term"=>"Sarcoma, Kaposi"}, {"id"=>"D012509", "term"=>"Sarcoma"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D004266", "term"=>"DNA Virus Infections"}, {"id"=>"D009383", "term"=>"Neoplasms, Vascular Tissue"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M15327", "name"=>"Sarcoma", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"id"=>"M15332", "name"=>"Sarcoma, Kaposi", "asFound"=>"Sarcoma, Kaposi", "relevance"=>"HIGH"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M20350", "name"=>"Neoplasms, Connective and Soft Tissue", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M9643", "name"=>"Herpesviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M12328", "name"=>"Neoplasms, Vascular Tissue", "relevance"=>"LOW"}, {"id"=>"T5284", "name"=>"Soft Tissue Sarcoma", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"id"=>"T3199", "name"=>"Kaposi Sarcoma", "asFound"=>"Kaposi's Sarcoma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000077556", "term"=>"Alitretinoin"}], "ancestors"=>[{"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D003879", "term"=>"Dermatologic Agents"}], "browseLeaves"=>[{"id"=>"M1834", "name"=>"Alitretinoin", "asFound"=>"Soft drink", "relevance"=>"HIGH"}, {"id"=>"M7074", "name"=>"Dermatologic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>27}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1997-08", "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["AIDS-Related Opportunistic Infections", "Sarcoma, Kaposi", "Antineoplastic Agents"], "conditions"=>["Sarcoma, Kaposi", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to see if ALRT1057 is safe and effective in treating patients with AIDS-related Kaposi's sarcoma (KS).", "detailedDescription"=>"Patients receive open-label ALRT1057 for 16 weeks, as tolerated. In the absence of unacceptable toxicity, patients may continue treatment indefinitely provided they continue to benefit from therapy and the study remains open and active.\n\nThirteen patients are treated initially. If at least one response is observed in these patients, up to 14 additional patients will be evaluated."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* HIV positive status and histologic confirmation of KS.\n* CD4 count \\> 200 mm3 (required of one-half of patients).\n* Minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions meeting criteria for \"indicator\" lesions.\n* Acceptable organ system function.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\nSerious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program.\n\nPrior Medication:\n\nExcluded:\n\n* Systemic therapy for KS within 30 days.\n* Local or topical therapy for KS indicative lesions within 60 days.\n* Systemic therapy with vitamin A in doses exceeding 15,000 IU per day or other retinoid class drug.\n\nRequired:\n\nApproved antiretroviral therapy."}, "identificationModule"=>{"nctId"=>"NCT00002188", "briefTitle"=>"A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.", "orgStudyIdInfo"=>{"id"=>"271A"}, "secondaryIdInfos"=>[{"id"=>"L1057-28"}, {"id"=>"96ACR-LIG2"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Alitretinoin", "type"=>"DRUG"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Anderson Clinical Research", "class"=>"INDUSTRY"}, "collaborators"=>[{"name"=>"Ligand Pharmaceuticals", "class"=>"INDUSTRY"}]}}}
