Nctid:
NCT00002445
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "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"=>"M15327", "name"=>"Sarcoma", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"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"=>"T6034", "name"=>"Quality of Life", "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"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>200}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2001-06", "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", "Placebos", "Sarcoma, Kaposi", "Antineoplastic Agents", "Treatment Outcome", "Quality of Life"], "conditions"=>["Sarcoma, Kaposi", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to see if it is safe and effective to use IM862 to treat Kaposi's sarcoma (KS) in AIDS patients.", "detailedDescription"=>"Patients are stratified by CD4 count, viral load, and prior systemic chemotherapy. Patients are randomized equally to receive either IM862 or placebo given intranasally every other day. Patients are seen every 4 weeks for 6 months or until disease progression to evaluate toxicity and efficacy. Quality of life is assessed before treatment, then every month for 6 months. At the end of the 6-month study evaluation period, patients with PR/CR (responders) remain on study and continue blinded treatment for an additional 6 months. For patients with stable disease (non-responders), the treatment assignment is unblinded and off-study IM862 compassionate use is offered for 6 months, regardless of treatment group. For patients with documented progressive disease (treatment failure), the treatment assignment is unblinded and off-study IM862 is offered for 6 months to any patient in the placebo group. For treatment failures in the IM862 group, IM862 is stopped and the patient is allowed other therapy options."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients may be eligible for this study if they:\n\n* Are HIV-positive.\n* Have AIDS-related Kaposi's sarcoma.\n* Have at least 5 skin or mouth sores that do not require chemotherapy.\n* Have been taking anti-HIV drugs for at least 8 weeks before study entry with no changes in the regimen.\n* Are at least 18 years old.\n* Agree to practice effective methods of birth control.\n\nExclusion Criteria\n\nPatients will not be eligible for this study if they:\n\n* Have an AIDS-related opportunistic infection (except for genital herpes) within 2 weeks of study entry.\n* Have had another type of cancer within the past 2 years (except for certain types of skin cancer, cervical cancer, or anal cancer).\n* Have a severe chest cold.\n* Have certain other serious medical conditions.\n* Have received certain medications, including chemotherapy, within the past 4 weeks.\n* Abuse alcohol or drugs.\n* Are pregnant or breast-feeding."}, "identificationModule"=>{"nctId"=>"NCT00002445", "briefTitle"=>"Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients", "nctIdAliases"=>["NCT00003879"], "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients With Muco-Cutaneous AIDS Associated Kaposi's Sarcoma", "orgStudyIdInfo"=>{"id"=>"306A"}, "secondaryIdInfos"=>[{"id"=>"KS-20898-01"}, {"id"=>"AMC-013"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"IM862", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90027", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"AIDS Healthcare Foundation", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90028", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"LAGLC", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"USC School of Medicine / Norris Cancer Hosp", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90048", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Tower ID Med Associates", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90095", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA Care Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"92103", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"UCSD Med Ctr", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"94110", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"UCSF - San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94117", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Conant Med Ctr", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"331361013", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Miami School of Medicine", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"33161", "city"=>"North Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"BioQuan Research Group", "geoPoint"=>{"lat"=>25.89009, "lon"=>-80.18671}}, {"zip"=>"30308", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"Grady Mem Hosp", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern Univ", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"46218", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Infectious Disease of Indiana", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"21231", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Oncology", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Massachusetts Gen Hosp", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02118", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Boston Med Ctr", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Beth Israel Med Ctr", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"63110", "city"=>"St. Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"Washington Univ School of Medicine", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"071032757", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"UMDNJ - New Jersey Med School", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"10461", "city"=>"Bronx", "state"=>"New York", "country"=>"United States", "facility"=>"Albert Einstein Comprehensive Ctr", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"10011", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"St Vincents Hosp / Clinical Research Program", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"New York Univ Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Mem Sloan - Kettering Cancer Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Columbia-Presbyterian Hosp", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"44106", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Case Western Reserve Univ", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"43210", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"Ohio State Univ", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}, {"zip"=>"19106", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Pennsylvania Oncology and Hematology Associates", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"37232", "city"=>"Nashville", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Vanderbilt Cancer Ctr", "geoPoint"=>{"lat"=>36.16589, "lon"=>-86.78444}}, {"zip"=>"98033", "city"=>"Kirkland", "state"=>"Washington", "country"=>"United States", "facility"=>"Cytran Inc", "geoPoint"=>{"lat"=>47.68149, "lon"=>-122.20874}}, {"zip"=>"98101", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Virginia Mason Med Ctr", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"zip"=>"98104", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Univ of Washington / Harborview Med Ctr", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"city"=>"Darlinghurst", "country"=>"Australia", "facility"=>"St Vincent's Hosp / Dept of Haematology", "geoPoint"=>{"lat"=>-33.87939, "lon"=>151.21925}}, {"city"=>"Prahan", "country"=>"Australia", "facility"=>"Alfred Hosp"}, {"city"=>"Randwick", "country"=>"Australia", "facility"=>"Prince of Wales Hosp", "geoPoint"=>{"lat"=>-33.91439, "lon"=>151.24895}}, {"city"=>"Sydney", "country"=>"Australia", "facility"=>"Taylors Square Clinic", "geoPoint"=>{"lat"=>-33.86785, "lon"=>151.20732}}, {"city"=>"Antwerpe", "country"=>"Belgium", "facility"=>"Inst of Tropical Medicine", "geoPoint"=>{"lat"=>51.21989, "lon"=>4.40346}}, {"city"=>"Brussels", "country"=>"Belgium", "facility"=>"CHU Saint Pierre", "geoPoint"=>{"lat"=>50.85045, "lon"=>4.34878}}, {"city"=>"Vancouver", "state"=>"British Columbia", "country"=>"Canada", "facility"=>"BC Cancer Agency", "geoPoint"=>{"lat"=>49.24966, "lon"=>-123.11934}}, {"city"=>"Ottawa", "state"=>"Ontario", "country"=>"Canada", "facility"=>"Ottawa General Hospital", "geoPoint"=>{"lat"=>45.41117, "lon"=>-75.69812}}, {"city"=>"Toronto", "state"=>"Ontario", "country"=>"Canada", "facility"=>"Sunnybrook Health Science Centre", "geoPoint"=>{"lat"=>43.70011, "lon"=>-79.4163}}, {"city"=>"Toronto", "state"=>"Ontario", "country"=>"Canada", "facility"=>"Toronto Gen Hosp", "geoPoint"=>{"lat"=>43.70011, "lon"=>-79.4163}}, {"city"=>"Montreal", "state"=>"Quebec", "country"=>"Canada", "facility"=>"Montreal Gen Hosp / Div of Clin Immuno and Allergy", "geoPoint"=>{"lat"=>45.50884, "lon"=>-73.58781}}], "overallOfficials"=>[{"name"=>"Parkash Gill", "role"=>"STUDY_CHAIR"}, {"name"=>"David Scadden", "role"=>"STUDY_CHAIR"}, {"name"=>"Ariela Noy", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Cytran", "class"=>"INDUSTRY"}}}}
