Nctid:
NCT00000954
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012514", "term"=>"Sarcoma, Kaposi"}, {"id"=>"D012509", "term"=>"Sarcoma"}], "ancestors"=>[{"id"=>"D018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D007239", "term"=>"Infections"}, {"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"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"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"=>"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"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D016049", "term"=>"Didanosine"}, {"id"=>"D016047", "term"=>"Zalcitabine"}, {"id"=>"D004317", "term"=>"Doxorubicin"}, {"id"=>"C506643", "term"=>"Liposomal doxorubicin"}, {"id"=>"D001761", "term"=>"Bleomycin"}, {"id"=>"D014750", "term"=>"Vincristine"}], "ancestors"=>[{"id"=>"D000903", "term"=>"Antibiotics, Antineoplastic"}, {"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"=>"D000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D050257", "term"=>"Tubulin Modulators"}, {"id"=>"D050256", "term"=>"Antimitotic Agents"}, {"id"=>"D050258", "term"=>"Mitosis Modulators"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}], "browseLeaves"=>[{"id"=>"M7492", "name"=>"Doxorubicin", "asFound"=>"Intravenous infusion", "relevance"=>"HIGH"}, {"id"=>"M227339", "name"=>"Liposomal doxorubicin", "asFound"=>"Intravenous infusion", "relevance"=>"HIGH"}, {"id"=>"M17495", "name"=>"Vincristine", "asFound"=>"Ratio", "relevance"=>"HIGH"}, {"id"=>"M5042", "name"=>"Bleomycin", "asFound"=>"Sedentary behavior", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M18548", "name"=>"Didanosine", "asFound"=>"Circulation", "relevance"=>"HIGH"}, {"id"=>"M18546", "name"=>"Zalcitabine", "asFound"=>"Anorectal", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M26197", "name"=>"Tubulin Modulators", "relevance"=>"LOW"}, {"id"=>"M26196", "name"=>"Antimitotic Agents", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>72}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1996-09", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-10-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Vincristine", "Sarcoma, Kaposi", "Zalcitabine", "Didanosine", "Doxorubicin", "Drug Evaluation", "Drug Interactions", "Drug Therapy, Combination", "Combined Modality Therapy", "Acquired Immunodeficiency Syndrome", "Antineoplastic Agents", "Antineoplastic Agents, Combined", "Antiviral Agents", "Bleomycin"], "conditions"=>["Sarcoma, Kaposi", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Mitsuyasu R, et al. Combination chemotherapy, adriamycin, bleomycin, vincristine (ABV) with dideoxyinosine (ddI) or dideoxycytidine (ddC) in advanced AIDS-related Kaposi's sarcoma (ACTG 163). Proc Annu Meet Am Assoc Cancer Res. 1995;14:A822"}, {"type"=>"BACKGROUND", "citation"=>"Mitsuyasu R, Gill P, Paredes J, Ambinder R, Ratner L, Feldstein M. Preliminary results of a phase I/II trial of combination chemotherapy (ABV) with ddI or ddC in AIDS-related Kaposi's sarcoma (ACTG 163). Int Conf AIDS. 1993 Jun 6-11;9(1):396 (abstract no PO-B12-1565)"}]}, "descriptionModule"=>{"briefSummary"=>"To determine the toxicity and response to treatment with cytotoxic chemotherapy using doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's sarcoma in combination with either didanosine (ddI) or zalcitabine (dideoxycytidine; ddC).\n\nAIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections.", "detailedDescription"=>"AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections.\n\nIn Phase I, eligible patients with advanced Kaposi's sarcoma are randomly assigned to either ddI or ddC in combination with DBV chemotherapy. On the average, patients receive 12-44 weeks of combined chemotherapy and antiretroviral therapy. If vincristine is deleted from Phase I because of excess neurotoxicity, it will not be administered as part of the combination chemotherapy if that treatment is continued in the Phase II study. The Phase II trial proceeds when at least six cycles (12 weeks) of DBV have been completed by six patients enrolled in Phase I, and an overall evaluation of tolerance to each combination treatment plan has been completed. Study medication is administered as in Phase I, with the possible deletion of vincristine. All patients who complete DBV chemotherapy with complete or partial response or stable disease will continue to receive the originally assigned investigational antiretroviral drug (ddC or ddI) for an additional 24 weeks."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nRequired:\n\n* Prophylaxis for Pneumocystis carinii pneumonia for all patients with CD4 cell counts \\< 200 cells/mm3.\n\nAllowed:\n\n* Chemoprophylaxis for candidiasis, MAC, and herpes simplex.\n* Up to 14-day courses of metronidazole.\n* Recombinant erythropoietin.\n* Granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte colony stimulating factor (G-CSF) for patients with ANC \\< 1000 cells/mm3.\n* Isoniazid for treatment of tuberculosis, with permission of the protocol chair, when given in conjunction with pyridoxine.\n\nPatients must have:\n\n* HIV infection.\n* Kaposi's sarcoma.\n\nFor patients \\< 18 years of age:\n\n* consent of parent or guardian.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Opportunistic infection requiring treatment with myelosuppressive antibiotics (unless on G-CSF or GM-CSF).\n* Other active malignancies except basal cell carcinoma of the skin or in situ cervical carcinoma.\n* Prior history or current clinical evidence of peripheral neuropathy (= or \\> grade 1), pancreatitis, intractable diarrhea, or active seizure disorder not controlled by antiseizure medication.\n* Significant pulmonary insufficiency (exertional dyspnea with minimal exertion, except that due to pulmonary Kaposi's sarcoma) or cardiac insufficiency (New York Heart Association status \\> 2).\n* Neuropsychiatric history or altered mental status that would prevent informed consent or that would not permit compliance with this protocol.\n\nConcurrent Medication:\n\nExcluded:\n\n* Myelosuppressive antibiotics (unless on G-CSF or GM-CSF).\n* Investigational agents other than drugs available on treatment IND and used for FDA sanctioned indications, or other antiviral, immunomodulating or antitumor drugs.\n* Drugs associated with peripheral neuropathy (other than ddI, ddC, or vincristine), including hydralazine, disulfiram, nitrofurantoin, cisplatin, diethyldithiocarbamate, gold, rifampin, chloramphenicol, clioquinol, ethambutol, ethionamide, glutethimide, sodium cyanate, and thalidomide.\n\nPatients with the following prior conditions or symptoms are excluded:\n\n* Neuropsychiatric history or altered mental status that would prevent informed consent or that would not permit compliance with this protocol.\n\nPrior Medication:\n\nExcluded:\n\n* Systemic treatment with doxorubicin, bleomycin, or vincristine.\n* Antitumor (Kaposi's sarcoma) drugs within 7 days of study entry.\n* Any investigational drug (other than drugs available on treatment IND and used for FDA sanctioned indications) within 14 days of study entry.\n* Neurotoxic drugs (other than ddI or ddC) within 30 days of study entry.\n* Intralesional injections to a Kaposi's sarcoma marker lesion within 30 days of study entry.\n\nPrior Treatment:\n\nExcluded:\n\n* Irradiation of a Kaposi's sarcoma marker lesion within 30 days of study entry.\n\nAlcohol consumption is strongly discouraged."}, "identificationModule"=>{"nctId"=>"NCT00000954", "briefTitle"=>"A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Phase I/II Study of Combination Chemotherapy (Adriamycin, Bleomycin, +/- Vincristine) and Dideoxyinosine (ddI) or Dideoxycytidine (ddC) in the Treatment of AIDS-Related Kaposi's Sarcoma", "orgStudyIdInfo"=>{"id"=>"ACTG 163"}, "secondaryIdInfos"=>[{"id"=>"11138", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Bleomycin sulfate", "type"=>"DRUG"}, {"name"=>"Vincristine sulfate", "type"=>"DRUG"}, {"name"=>"Doxorubicin hydrochloride", "type"=>"DRUG"}, {"name"=>"Zalcitabine", "type"=>"DRUG"}, {"name"=>"Didanosine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"USC CRS", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90095", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA CARE Center CRS", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Ucsf Aids Crs", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"80262", "city"=>"Aurora", "state"=>"Colorado", "country"=>"United States", "facility"=>"University of Colorado Hospital CRS", "geoPoint"=>{"lat"=>39.72943, "lon"=>-104.83192}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern University CRS", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Rush Univ. Med. Ctr. ACTG CRS", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ. School of Medicine, Infectious Disease Research Clinic", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Adult AIDS CRS", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"02118", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Bmc Actg Crs", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"city"=>"Saint Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"Washington U CRS", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"14215", "city"=>"Buffalo", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY - Buffalo, Erie County Medical Ctr.", "geoPoint"=>{"lat"=>42.88645, "lon"=>-78.87837}}, {"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Memorial Sloan-Kettering Cancer Ctr.", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"27599", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Unc Aids Crs", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"zip"=>"43210", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"The Ohio State Univ. AIDS CRS", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}], "overallOfficials"=>[{"name"=>"Mitsuyasu RT", "role"=>"STUDY_CHAIR"}, {"name"=>"Gill PS", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Novum", "class"=>"INDUSTRY"}, {"name"=>"Bristol-Myers Squibb", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
