Nctid:
NCT00002003
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008223", "term"=>"Lymphoma"}, {"id"=>"D008228", "term"=>"Lymphoma, Non-Hodgkin"}, {"id"=>"D000069293", "term"=>"Plasmablastic Lymphoma"}, {"id"=>"D016400", "term"=>"Lymphoma, Large-Cell, Immunoblastic"}], "ancestors"=>[{"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D016403", "term"=>"Lymphoma, Large B-Cell, Diffuse"}, {"id"=>"D016393", "term"=>"Lymphoma, B-Cell"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M11220", "name"=>"Lymphoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M11222", "name"=>"Lymphoma, Non-Hodgkin", "asFound"=>"Lymphoma, Non-Hodgkin", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M381", "name"=>"Plasmablastic Lymphoma", "asFound"=>"Immunoblastic Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M18830", "name"=>"Lymphoma, Large-Cell, Immunoblastic", "asFound"=>"Immunoblastic Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M11225", "name"=>"Lymphoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M11203", "name"=>"Lymphatic Diseases", "relevance"=>"LOW"}, {"id"=>"M10206", "name"=>"Immunoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M18831", "name"=>"Lymphoma, Large B-Cell, Diffuse", "relevance"=>"LOW"}, {"id"=>"M18828", "name"=>"Lymphoma, B-Cell", "relevance"=>"LOW"}, {"id"=>"T3543", "name"=>"Lymphosarcoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T4586", "name"=>"Plasmablastic Lymphoma", "asFound"=>"Immunoblastic Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T3539", "name"=>"Lymphoma, Large-cell, Immunoblastic", "asFound"=>"Immunoblastic Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T640", "name"=>"B-cell Lymphoma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D005047", "term"=>"Etoposide"}, {"id"=>"D008942", "term"=>"Mitoxantrone"}], "ancestors"=>[{"id"=>"D000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D059005", "term"=>"Topoisomerase II Inhibitors"}, {"id"=>"D059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000700", "term"=>"Analgesics"}, {"id"=>"D018689", "term"=>"Sensory System Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M8191", "name"=>"Etoposide", "asFound"=>"Different", "relevance"=>"HIGH"}, {"id"=>"M341643", "name"=>"Etoposide phosphate", "relevance"=>"LOW"}, {"id"=>"M11908", "name"=>"Mitoxantrone", "asFound"=>"Inactive", "relevance"=>"HIGH"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1992-03", "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"=>["Mitoxantrone", "Lymphoma, Large-Cell", "Etoposide", "Acquired Immunodeficiency Syndrome"], "conditions"=>["Lymphoma, Non-Hodgkin", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride ( Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have the following:\n\n* Positive HIV antibody, positive HIV culture or antigen capture, or prior diagnosis of AIDS by the CDC criteria.\n* Diagnosis by pathological examination of large cell or immunoblastic lymphoma within measurable or evaluable disease.\n* Pneumocystis carinii pneumonia (PCP) prophylaxis during the course of the study.\n* Signed written informed consent.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.\n* Stage IE Central Nervous System lymphomas.\n\nPatients with the following are excluded:\n\n* More than one previous treatment for lymphoma.\n* Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.\n* Conditions that preclude obtaining an informed consent.\n* Not accessible for scheduled treatment visits or follow-up.\n* Stage IE Central Nervous System (CNS) lymphomas.\n\nPrior Medication:\n\nExcluded within 2 weeks of study entry:\n\n* Zidovudine.\n* Excluded:\n* Doxorubicin dosing = or \\> 300 mg/m2.\n\nPrior Treatment:\n\nExcluded:\n\n* Received more than one previous treatment regimen for lymphoma.\n\nRequired:\n\n* Prophylactic treatment for Pneumocystis carinii pneumonia (PCP) prophylaxis."}, "identificationModule"=>{"nctId"=>"NCT00002003", "briefTitle"=>"Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas", "orgStudyIdInfo"=>{"id"=>"055A"}, "secondaryIdInfos"=>[{"id"=>"3-100"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Mitoxantrone hydrochloride", "type"=>"DRUG"}, {"name"=>"Etoposide", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"071032714", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"UMDNJ - New Jersy Med School", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"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"=>"10019", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Saint Luke's - Roosevelt Hosp Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Lederle Laboratories", "class"=>"INDUSTRY"}}}}
