Nctid:
NCT00002137
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012514", "term"=>"Sarcoma, Kaposi"}, {"id"=>"D012509", "term"=>"Sarcoma"}], "ancestors"=>[{"id"=>"D018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D007239", "term"=>"Infections"}, {"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"=>"M15327", "name"=>"Sarcoma", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M15332", "name"=>"Sarcoma, Kaposi", "asFound"=>"Sarcoma, Kaposi", "relevance"=>"HIGH"}, {"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", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1996-04", "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"=>["Neoplasms", "Sarcoma, Kaposi", "Acquired Immunodeficiency Syndrome", "Antineoplastic Agents", "tecogalan"], "conditions"=>["Sarcoma, Kaposi", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Tulpule A, Snyder JC, Espina BM, Higashi L, Satomi M, Lombardy EE. A phase I study of tecogalan, a novel angiogenesis inhibitor in the treatment of AIDS-related Kaposi's sarcoma and solid tumors (meeting abstract). Gill PS. Blood 1994;84(10, Suppl 1):248a"}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules.", "detailedDescription"=>"Patients receive intravenous DS-4152 by infusion weekly for 4 weeks, followed by 2 weeks of rest; courses may repeat. Patients undergo weekly follow-up. A punch biopsy will be obtained from patients with Kaposi's sarcoma."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* Kaposi's sarcoma plus HIV infection OR metastatic solid tumor.\n* Life expectancy of at least 12 weeks.\n* NO symptomatic AIDS-defining opportunistic infection within the past 4 weeks.\n* Recovered from toxicity of any prior anticancer therapy.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Leukemia or lymphoma.\n* Current gastrointestinal bleeding by stool guaiac.\n* Extensive bone metastases or significant radiographic osteoporosis in patients with solid tumors.\n* Active heart disease such as uncontrolled angina, uncompensated congestive heart failure, or dysrhythmias requiring antiarrhythmics.\n* Acute intercurrent infection other than genital herpes.\n* Symptomatic or known central nervous system involvement (including brain metastases) unless stable and off therapy.\n\nConcurrent Medication:\n\nExcluded:\n\n* Other anticancer therapy.\n* Other investigational agents.\n\nPatients with the following prior conditions are excluded:\n\n* History of acute or chronic gastrointestinal bleeding or inflammatory bowel disease.\n* History of myocardial infarction within past 6 months.\n\nPrior Medication:\n\nExcluded:\n\n* Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C).\n* Investigational agents within the past 4 weeks."}, "identificationModule"=>{"nctId"=>"NCT00002137", "briefTitle"=>"A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4", "orgStudyIdInfo"=>{"id"=>"088B"}, "secondaryIdInfos"=>[{"id"=>"4152A-PRT002"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Tecogalan sodium", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Kenneth Norris Jr Cancer Ctr / USC", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Daiichi Pharmaceuticals", "class"=>"INDUSTRY"}}}}
