Nctid:
NCT00001059
Payload:
{"FullStudy"=>{"Rank"=>498274, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000012514", "ConditionMeshTerm"=>"Sarcoma, Kaposi"}, {"ConditionMeshId"=>"D000012509", "ConditionMeshTerm"=>"Sarcoma"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000018204", "ConditionAncestorTerm"=>"Neoplasms, Connective and Soft Tissue"}, {"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000014777", "ConditionAncestorTerm"=>"Virus Diseases"}, {"ConditionAncestorId"=>"D000006566", "ConditionAncestorTerm"=>"Herpesviridae Infections"}, {"ConditionAncestorId"=>"D000004266", "ConditionAncestorTerm"=>"DNA Virus Infections"}, {"ConditionAncestorId"=>"D000009383", "ConditionAncestorTerm"=>"Neoplasms, Vascular Tissue"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16355", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10283", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6368", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15327", "ConditionBrowseLeafName"=>"Sarcoma", "ConditionBrowseLeafAsFound"=>"Sarcoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M3522", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18250", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10199", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15332", "ConditionBrowseLeafName"=>"Sarcoma, Kaposi", "ConditionBrowseLeafAsFound"=>"Sarcoma, Kaposi", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M20350", "ConditionBrowseLeafName"=>"Neoplasms, Connective and Soft Tissue", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12315", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17522", "ConditionBrowseLeafName"=>"Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9643", "ConditionBrowseLeafName"=>"Herpesviridae Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7442", "ConditionBrowseLeafName"=>"DNA Virus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12328", "ConditionBrowseLeafName"=>"Neoplasms, Vascular Tissue", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T5284", "ConditionBrowseLeafName"=>"Soft Tissue Sarcoma", "ConditionBrowseLeafAsFound"=>"Sarcoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T3199", "ConditionBrowseLeafName"=>"Kaposi Sarcoma", "ConditionBrowseLeafAsFound"=>"Kaposi's Sarcoma", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000004317", "InterventionMeshTerm"=>"Doxorubicin"}, {"InterventionMeshId"=>"C000506643", "InterventionMeshTerm"=>"Liposomal doxorubicin"}, {"InterventionMeshId"=>"D000001761", "InterventionMeshTerm"=>"Bleomycin"}, {"InterventionMeshId"=>"D000014750", "InterventionMeshTerm"=>"Vincristine"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000903", "InterventionAncestorTerm"=>"Antibiotics, Antineoplastic"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000059005", "InterventionAncestorTerm"=>"Topoisomerase II Inhibitors"}, {"InterventionAncestorId"=>"D000059003", "InterventionAncestorTerm"=>"Topoisomerase Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000000972", "InterventionAncestorTerm"=>"Antineoplastic Agents, Phytogenic"}, {"InterventionAncestorId"=>"D000050257", "InterventionAncestorTerm"=>"Tubulin Modulators"}, {"InterventionAncestorId"=>"D000050256", "InterventionAncestorTerm"=>"Antimitotic Agents"}, {"InterventionAncestorId"=>"D000050258", "InterventionAncestorTerm"=>"Mitosis Modulators"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M7492", "InterventionBrowseLeafName"=>"Doxorubicin", "InterventionBrowseLeafAsFound"=>"Alcohol", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M17495", "InterventionBrowseLeafName"=>"Vincristine", "InterventionBrowseLeafAsFound"=>"Intubation", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M227339", "InterventionBrowseLeafName"=>"Liposomal doxorubicin", "InterventionBrowseLeafAsFound"=>"Alcohol", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M5042", "InterventionBrowseLeafName"=>"Bleomycin", "InterventionBrowseLeafAsFound"=>"Hospital stay", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M1945", "InterventionBrowseLeafName"=>"Lenograstim", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4222", "InterventionBrowseLeafName"=>"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4224", "InterventionBrowseLeafName"=>"Antibiotics, Antitubercular", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M29348", "InterventionBrowseLeafName"=>"Topoisomerase Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7951", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M26197", "InterventionBrowseLeafName"=>"Tubulin Modulators", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M26196", "InterventionBrowseLeafName"=>"Antimitotic Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"120"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"April 2012", "CompletionDateStruct"=>{"CompletionDate"=>"August 1998", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"April 13, 2012", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"April 17, 2012", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Vincristine", "Sarcoma, Kaposi", "Liposomes", "Doxorubicin", "Drug Therapy, Combination", "Granulocyte Colony-Stimulating Factor", "Acquired Immunodeficiency Syndrome", "Bleomycin", "Drug Carriers"]}, "ConditionList"=>{"Condition"=>["Sarcoma, Kaposi", "HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferenceType"=>"background", "ReferenceCitation"=>"Mitsuyasu R, et al. Comparison study of liposomal doxorubicin (DOX) alone or with bleomycin and vincristine (DBV) for treatment of advanced AIDS-associated Kaposi's sarcoma (AIDS-KS): AIDS Clinical Trial Group (ACTG) protocol 286 (meeting abstract). Proc Annu Meet Am Soc Clin Oncol. 1997;16:A191"}]}}, "DescriptionModule"=>{"BriefSummary"=>"To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life.\n\nLiposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.", "DetailedDescription"=>"Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.\n\nPatients are randomized to receive intravenous DOX-SL alone or in combination with vincristine/bleomycin every 2 weeks. Filgrastim ( granulocyte colony-stimulating factor; G-CSF ) may be given as needed for neutropenia.\n\nAS PER AMENDMENT 11/7/96: Based on interim review data, it is recommended that subjects receiving DOX-SL plus vincristine/bleomycin have vincristine/bleomycin discontinued and receive DOX-SL alone unless, in the opinion of the treating physician, they are benefitting from the DOX-SL plus vincristine/bleomycin regimen."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\nG-CSF.\nLicensed or Treatment IND-approved antiretrovirals ( AZT, ddI, ddC, d4T ).\nPCP prophylaxis (required if CD4 count < 200 cells/mm3).\nChemoprophylaxis or maintenance for bacterial infections, candidiasis, MAC, and herpes simplex.\nUp to 14 days of metronidazole.\nRecombinant erythropoietin.\n\nPatients must have:\n\nDocumented HIV infection.\nAdvanced stage Kaposi's sarcoma.\nNo active acute opportunistic infection.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nSignificant pulmonary insufficiency (unless due to pulmonary KS).\nSignificant cardiac insufficiency.\nOther active malignancies except for basal or squamous cell carcinoma of the skin or in situ cervical cancer.\nGrade 2 or worse peripheral neuropathy.\nAltered mental status that prevents informed consent.\nActive Mycobacterium tuberculosis.\nHypersensitivity or allergic reaction to any study drugs or E. coli-derived medications such as filgrastim (G-CSF).\n\nConcurrent Medication:\n\nExcluded:\n\nGM-CSF.\nDrugs associated with peripheral neuropathy (other than approved antiretrovirals and vincristine).\nMulti-drug therapy for active Mycobacterium tuberculosis (although isoniazid and pyridoxine is allowed as treatment for a positive PPD, with permission of study chair).\n\nConcurrent Treatment:\n\nExcluded:\n\nRadiation therapy to study marker lesions.\n\nPatients with the following prior condition are excluded:\n\nNeuropsychiatric history.\n\nPrior Medication:\n\nExcluded:\n\nAny anti-KS therapy within 21 days prior to study entry.\nPrior systemic therapy with any anthracycline (including liposomal anthracyclines), vincristine, or bleomycin.\nAny investigational drug (other than those available through Treatment IND and used for FDA-sanctioned purposes) within 14 days prior to study entry.\n\nPER AMENDMENT 11/29/95:\n\nNo more than 2 cycles of any systemic chemotherapy for Kaposi's sarcoma."}, "IdentificationModule"=>{"NCTId"=>"NCT00001059", "BriefTitle"=>"Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"Comparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 286"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"11262", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Doxorubicin hydrochloride (liposomal)", "InterventionType"=>"Drug"}, {"InterventionName"=>"Filgrastim", "InterventionType"=>"Drug"}, {"InterventionName"=>"Bleomycin sulfate", "InterventionType"=>"Drug"}, {"InterventionName"=>"Vincristine sulfate", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"35294", "LocationCity"=>"Birmingham", "LocationState"=>"Alabama", "LocationCountry"=>"United States", "LocationFacility"=>"Alabama Therapeutics CRS"}, {"LocationZip"=>"90033", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"USC CRS"}, {"LocationZip"=>"90095", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"UCLA CARE Center CRS"}, {"LocationCity"=>"San Francisco", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Ucsf Aids Crs"}, {"LocationZip"=>"80262", "LocationCity"=>"Aurora", "LocationState"=>"Colorado", "LocationCountry"=>"United States", "LocationFacility"=>"University of Colorado Hospital CRS"}, {"LocationZip"=>"33136", "LocationCity"=>"Miami", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Miami AIDS CRS"}, {"LocationZip"=>"96813", "LocationCity"=>"Honolulu", "LocationState"=>"Hawaii", "LocationCountry"=>"United States", "LocationFacility"=>"Queens Med. Ctr."}, {"LocationZip"=>"96816", "LocationCity"=>"Honolulu", "LocationState"=>"Hawaii", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Hawaii at Manoa, Leahi Hosp."}, {"LocationZip"=>"60611", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Northwestern University CRS"}, {"LocationZip"=>"60612", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Rush Univ. Med. Ctr. ACTG CRS"}, {"LocationZip"=>"46202", "LocationCity"=>"Indianapolis", "LocationState"=>"Indiana", "LocationCountry"=>"United States", "LocationFacility"=>"Indiana Univ. School of Medicine, Infectious Disease Research Clinic"}, {"LocationZip"=>"02118", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Bmc Actg Crs"}, {"LocationZip"=>"02215", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Beth Israel Deaconess - East Campus A0102 CRS"}, {"LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Massachusetts General Hospital ACTG CRS"}, {"LocationZip"=>"63110", "LocationCity"=>"St. Louis", "LocationState"=>"Missouri", "LocationCountry"=>"United States", "LocationFacility"=>"Washington U CRS"}, {"LocationZip"=>"14215", "LocationCity"=>"Buffalo", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"SUNY - Buffalo, Erie County Medical Ctr."}, {"LocationZip"=>"10021", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Memorial Sloan-Kettering Cancer Ctr."}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Mitsuyasu R", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Krown S", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Von Roenn JH", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"Sequus Pharmaceuticals", "CollaboratorClass"=>"INDUSTRY"}, {"CollaboratorName"=>"Amgen", "CollaboratorClass"=>"INDUSTRY"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
