Nctid:
NCT00000626
Payload:
{"FullStudy"=>{"Rank"=>498704, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000006689", "ConditionMeshTerm"=>"Hodgkin Disease"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000007154", "ConditionAncestorTerm"=>"Immune System Diseases"}, {"ConditionAncestorId"=>"D000008223", "ConditionAncestorTerm"=>"Lymphoma"}, {"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000008232", "ConditionAncestorTerm"=>"Lymphoproliferative Disorders"}, {"ConditionAncestorId"=>"D000008206", "ConditionAncestorTerm"=>"Lymphatic Diseases"}, {"ConditionAncestorId"=>"D000007160", "ConditionAncestorTerm"=>"Immunoproliferative Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16355", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10283", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6368", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9751", "ConditionBrowseLeafName"=>"Hodgkin Disease", "ConditionBrowseLeafAsFound"=>"Hodgkin's Disease", "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"=>"M3735", "ConditionBrowseLeafName"=>"AIDS-Related Complex", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10200", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11220", "ConditionBrowseLeafName"=>"Lymphoma", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12315", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11225", "ConditionBrowseLeafName"=>"Lymphoproliferative Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11203", "ConditionBrowseLeafName"=>"Lymphatic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10206", "ConditionBrowseLeafName"=>"Immunoproliferative Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T2817", "ConditionBrowseLeafName"=>"Hodgkin Lymphoma", "ConditionBrowseLeafAsFound"=>"Hodgkin's Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T3543", "ConditionBrowseLeafName"=>"Lymphosarcoma", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Blood and Lymph Conditions", "ConditionBrowseBranchAbbrev"=>"BC15"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000004317", "InterventionMeshTerm"=>"Doxorubicin"}, {"InterventionMeshId"=>"C000506643", "InterventionMeshTerm"=>"Liposomal doxorubicin"}, {"InterventionMeshId"=>"D000001761", "InterventionMeshTerm"=>"Bleomycin"}, {"InterventionMeshId"=>"D000003606", "InterventionMeshTerm"=>"Dacarbazine"}, {"InterventionMeshId"=>"D000014747", "InterventionMeshTerm"=>"Vinblastine"}]}, "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"=>"D000018906", "InterventionAncestorTerm"=>"Antineoplastic Agents, Alkylating"}, {"InterventionAncestorId"=>"D000000477", "InterventionAncestorTerm"=>"Alkylating Agents"}, {"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"=>"M227339", "InterventionBrowseLeafName"=>"Liposomal doxorubicin", "InterventionBrowseLeafAsFound"=>"Alcohol", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M5042", "InterventionBrowseLeafName"=>"Bleomycin", "InterventionBrowseLeafAsFound"=>"Hospital stay", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M1945", "InterventionBrowseLeafName"=>"Lenograstim", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17492", "InterventionBrowseLeafName"=>"Vinblastine", "InterventionBrowseLeafAsFound"=>"Created", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M6809", "InterventionBrowseLeafName"=>"Dacarbazine", "InterventionBrowseLeafAsFound"=>"4 times", "InterventionBrowseLeafRelevance"=>"high"}, {"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"=>"M20942", "InterventionBrowseLeafName"=>"Antineoplastic Agents, Alkylating", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3820", "InterventionBrowseLeafName"=>"Alkylating Agents", "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"=>"27"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"February 1999", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"October 26, 2021", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"October 27, 2021", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Granulocyte Colony-Stimulating Factor", "Acquired Immunodeficiency Syndrome", "Antineoplastic Agents, Combined", "AIDS-Related Complex", "Hodgkin Disease", "ABVD protocol"]}, "ConditionList"=>{"Condition"=>["HIV Infections", "Hodgkin's Disease"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"11035615", "ReferenceType"=>"background", "ReferenceCitation"=>"Levine AM, Li P, Cheung T, Tulpule A, Von Roenn J, Nathwani BN, Ratner L. Chemotherapy consisting of doxorubicin, bleomycin, vinblastine, and dacarbazine with granulocyte-colony-stimulating factor in HIV-infected patients with newly diagnosed Hodgkin's disease: a prospective, multi-institutional AIDS clinical trials group study (ACTG 149). J Acquir Immune Defic Syndr. 2000 Aug 15;24(5):444-50. doi: 10.1097/00126334-200008150-00009."}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Levine AM, et al. Prospective, multicenter phase II trial of ABVD chemotherapy with G-CSF in HIV-infected patients with Hodgkin's disease (HD): AIDS Clincial Trials Group (ACTG) Study 149. Proc Annu Meet Am Soc Clin Oncol. 1997;16:A194"}]}}, "DescriptionModule"=>{"BriefSummary"=>"Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease.\n\nSecondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen.\n\nAddition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.", "DetailedDescription"=>"Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.\n\nStudy drugs are administered in 28-day cycles to twenty-seven HIV-infected patients with Hodgkin's disease. ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) is administered on days 1 and 15 of each cycle, and G-CSF is given on days 2 through 14 and 16 through 28 of each cycle. All patients receive four cycles of treatment and are then restaged. Patients with a complete response (CR) following the initial four cycles receive two additional cycles of ABVD / G-CSF. Patients with a partial response following the initial four cycles receive two additional cycles of ABVD / G-CSF and are again restaged; those who have achieved a CR at that point then receive two more cycles, while those without CR discontinue study therapy. Patients with disease progression following the initial four cycles of therapy discontinue treatment on the study. Concomitant PCP prophylaxis is administered."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"12 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nRequired:\n\nPCP prophylaxis consisting of Bactrim, aerosolized pentamidine, or dapsone.\n\nRecommended:\n\nAntiemetic therapy within 30 minutes of chemotherapy.\n\nAllowed:\n\nAntiretroviral medication after two cycles of chemotherapy, provided the patient has not experienced grade 3 neutropenia while on chemotherapy or on previous antiretroviral therapy.\nAcetaminophen and/or nonsteroidal anti-inflammatory agents.\nBone marrow-suppressive agents, such as ganciclovir, Fansidar, Bactrim, and dapsone.\nMaintenance therapy for chronic opportunistic infection.\n\nConcurrent Treatment:\n\nAllowed:\n\nCranial irradiation (2400 rads) for patients with CNS involvement.\n\nPatients must have:\n\nDocumented HIV infection or diagnosis of AIDS.\nHodgkin's disease.\nConsent of parent or guardian and have care directly supervised by a pediatric oncologist if under 18 years of age.\n\nPrior Medication:\n\nAllowed:\n\nMaintenance therapy for opportunistic infections.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nSecond primary cancer other than Kaposi's sarcoma that does not require systemic therapy, nonmelanomatous skin cancer, Bowen's disease, or carcinoma in situ of the cervix.\nAcute, active bacterial or opportunistic infection requiring ongoing therapy if such therapy has been initiated within the past 2 weeks.\nKnown hypersensitivity (e.g., anaphylactoid reaction, bronchospasm) to E. coli-derived proteins.\n\nPrior Medication:\n\nExcluded:\n\nPrior chemotherapy for Hodgkin's disease.\nAntiretroviral therapy within 2 weeks prior to study entry.\n\nPrior Treatment:\n\nExcluded:\n\nPrior radiotherapy for Hodgkin's disease."}, "IdentificationModule"=>{"NCTId"=>"NCT00000626", "BriefTitle"=>"Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 149"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"11124", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Vinblastine sulfate", "InterventionType"=>"Drug"}, {"InterventionName"=>"Dacarbazine", "InterventionType"=>"Drug"}, {"InterventionName"=>"Filgrastim", "InterventionType"=>"Drug"}, {"InterventionName"=>"Bleomycin sulfate", "InterventionType"=>"Drug"}, {"InterventionName"=>"Doxorubicin hydrochloride", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"35294", "LocationCity"=>"Birmingham", "LocationState"=>"Alabama", "LocationCountry"=>"United States", "LocationFacility"=>"Alabama Therapeutics CRS"}, {"LocationZip"=>"900331079", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"USC CRS"}, {"LocationZip"=>"60611", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Northwestern University CRS"}, {"LocationZip"=>"462025250", "LocationCity"=>"Indianapolis", "LocationState"=>"Indiana", "LocationCountry"=>"United States", "LocationFacility"=>"Indiana Univ. School of Medicine, Infectious Disease Research Clinic"}, {"LocationZip"=>"63112", "LocationCity"=>"Saint Louis", "LocationState"=>"Missouri", "LocationCountry"=>"United States", "LocationFacility"=>"St. Louis ConnectCare, Infectious Diseases Clinic"}, {"LocationCity"=>"Saint Louis", "LocationState"=>"Missouri", "LocationCountry"=>"United States", "LocationFacility"=>"Washington U CRS"}, {"LocationCity"=>"Buffalo", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"SUNY - Buffalo, Erie County Medical Ctr."}, {"LocationZip"=>"432101228", "LocationCity"=>"Columbus", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"The Ohio State Univ. AIDS CRS"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Levine A", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"Amgen", "CollaboratorClass"=>"INDUSTRY"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
