Nctid:
NCT00000807
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012514", "term"=>"Sarcoma, Kaposi"}, {"id"=>"D000012509", "term"=>"Sarcoma"}], "ancestors"=>[{"id"=>"D000018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D000004266", "term"=>"DNA Virus Infections"}, {"id"=>"D000009383", "term"=>"Neoplasms, Vascular Tissue"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M15327", "name"=>"Sarcoma", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"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", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"id"=>"T3199", "name"=>"Kaposi Sarcoma", "asFound"=>"Kaposi's Sarcoma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000005047", "term"=>"Etoposide"}], "ancestors"=>[{"id"=>"D000000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000059005", "term"=>"Topoisomerase II Inhibitors"}, {"id"=>"D000059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M8191", "name"=>"Etoposide", "asFound"=>"Complete", "relevance"=>"HIGH"}, {"id"=>"M341643", "name"=>"Etoposide phosphate", "relevance"=>"LOW"}, {"id"=>"M29348", "name"=>"Topoisomerase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>41}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"2000-07", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-10-28", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Sarcoma, Kaposi", "Etoposide", "Acquired Immunodeficiency Syndrome"], "conditions"=>["Sarcoma, Kaposi", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Mans D, Sprinz E, Sander I, Kalakun F, Jung G, Prolla G, Schwartsmann G. A phase II study of oral etoposide (VP-16) in AIDS-related Kaposi's sarcoma (KS). Int Conf AIDS. 1994 Aug 7-12;10(1):173 (abstract no PB0118)"}, {"pmid"=>"12149296", "type"=>"BACKGROUND", "citation"=>"Evans SR, Krown SE, Testa MA, Cooley TP, Von Roenn JH. Phase II evaluation of low-dose oral etoposide for the treatment of relapsed or progressive AIDS-related Kaposi's sarcoma: an AIDS Clinical Trials Group clinical study. J Clin Oncol. 2002 Aug 1;20(15):3236-41. doi: 10.1200/JCO.2002.12.038."}]}, "descriptionModule"=>{"briefSummary"=>"To assess the toxicity, tumor response rate, and effect on quality of life of daily low-dose etoposide administered for 7 consecutive days every other week in patients with AIDS-related Kaposi's sarcoma that has relapsed or progressed after systemic chemotherapy.\n\nEtoposide may be at least as, or even more, effective and less myelotoxic when given in low doses over prolonged periods of time.", "detailedDescription"=>"Etoposide may be at least as, or even more, effective and less myelotoxic when given in low doses over prolonged periods of time.\n\nPatients receive low-dose oral etoposide on days 1 through 7 of every 2-week cycle. Patients who achieve a complete or partial response after two cycles and have no toxicity greater than grade 2 may have their dose escalated for subsequent cycles. If there are no responses to therapy among the first 14 evaluable patients, the study will close; if there is at least one objective response to therapy among the first 14 evaluable patients, enrollment will continue until all 41 patients are enrolled. Patients continue therapy until maximal tumor response (either stable disease or complete response) is achieved or disease progression occurs."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Maintenance therapy for opportunistic infections.\n\nPatients must have:\n\n* HIV infection.\n* Kaposi's sarcoma that has relapsed or progressed.\n* Mucocutaneous lesions (15 or more) and/or symptomatic mucosal lesions and/or visceral Kaposi's sarcoma (symptomatic lymphedema qualifies patients in the absence of these three conditions).\n* NO active acute opportunistic infections requiring treatment with myelosuppressive antibiotics (maintenance for OIs is permitted).\n* Consent of parent or guardian if less than 18 years of age.\n\nNOTE:\n\n* This study is approved for prisoner participation.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Other active malignancies except basal cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* Grade 3 or worse peripheral neuropathy.\n* Altered mental status that would prevent informed consent or prevent study compliance.\n\nPatients with the following prior condition are excluded:\n\nNeuropsychiatric history.\n\nPrior Medication:\n\nExcluded:\n\n* Prior etoposide.\n* Any other anti-KS drugs within 14 days prior to study entry.\n* Any investigational drug other than antiretrovirals within 14 days prior to study entry.\n* Any prior investigational agent, if given as the ONLY prior treatment for KS.\n\nPrior Treatment:\n\nExcluded:\n\n* Radiation therapy within 7 days prior to study entry.\n\nContinued alcohol consumption or continued intravenous drug use that would impair ability to comply with study requirements."}, "identificationModule"=>{"nctId"=>"NCT00000807", "briefTitle"=>"Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy", "orgStudyIdInfo"=>{"id"=>"ACTG 269"}, "secondaryIdInfos"=>[{"id"=>"11245", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Etoposide", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35294", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Univ of Alabama at Birmingham", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"900331079", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"K Norris Cancer Hosp / Los Angeles County - USC Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"900331079", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Univ of Southern California / LA County USC Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"941102859", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"80262", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"Denver Dept of Health and Hosps", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"80262", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"Univ of Colorado Health Sciences Ctr", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"065102483", "city"=>"New Haven", "state"=>"Connecticut", "country"=>"United States", "facility"=>"Yale Univ / New Haven", "geoPoint"=>{"lat"=>41.30815, "lon"=>-72.92816}}, {"zip"=>"331361013", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Miami School of Medicine", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern Univ Med School", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"462025250", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ Hosp", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"02118", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Boston Med Ctr", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"122083479", "city"=>"Albany", "state"=>"New York", "country"=>"United States", "facility"=>"Adirondack Med Ctr at Saranac Lake", "geoPoint"=>{"lat"=>42.65258, "lon"=>-73.75623}}, {"zip"=>"122083479", "city"=>"Albany", "state"=>"New York", "country"=>"United States", "facility"=>"Albany Med College / Division of HIV Medicine A158", "geoPoint"=>{"lat"=>42.65258, "lon"=>-73.75623}}, {"zip"=>"122083479", "city"=>"Albany", "state"=>"New York", "country"=>"United States", "facility"=>"Mid - Hudson Care Ctr", "geoPoint"=>{"lat"=>42.65258, "lon"=>-73.75623}}, {"zip"=>"14215", "city"=>"Buffalo", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / Erie County Med Ctr at Buffalo", "geoPoint"=>{"lat"=>42.88645, "lon"=>-78.87837}}, {"zip"=>"11373", "city"=>"Elmhurst", "state"=>"New York", "country"=>"United States", "facility"=>"City Hosp Ctr at Elmhurst / Mount Sinai Hosp", "geoPoint"=>{"lat"=>40.73649, "lon"=>-73.87791}}, {"zip"=>"10019", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Saint Clare's Hosp and Health Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Mount Sinai Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"100323784", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Columbia Presbyterian Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"29169", "city"=>"West Columbia", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Julio Arroyo", "geoPoint"=>{"lat"=>33.99349, "lon"=>-81.07398}}], "overallOfficials"=>[{"name"=>"Von Roenn JH", "role"=>"STUDY_CHAIR"}, {"name"=>"Paredes J", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Bristol-Myers Squibb", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
