Nctid:
NCT00002574
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007938", "term"=>"Leukemia"}, {"id"=>"D007951", "term"=>"Leukemia, Myeloid"}, {"id"=>"D015464", "term"=>"Leukemia, Myelogenous, Chronic, BCR-ABL Positive"}], "ancestors"=>[{"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D006402", "term"=>"Hematologic Diseases"}, {"id"=>"D009196", "term"=>"Myeloproliferative Disorders"}, {"id"=>"D001855", "term"=>"Bone Marrow Diseases"}, {"id"=>"D002908", "term"=>"Chronic Disease"}, {"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M10945", "name"=>"Leukemia", "asFound"=>"Leukemia", "relevance"=>"HIGH"}, {"id"=>"M10955", "name"=>"Leukemia, Myeloid", "asFound"=>"Myelogenous Leukemia", "relevance"=>"HIGH"}, {"id"=>"M18123", "name"=>"Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "asFound"=>"Chronic myelogenous leukemia", "relevance"=>"HIGH"}, {"id"=>"M18125", "name"=>"Leukemia, Myeloid, Chronic-Phase", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"M12149", "name"=>"Myeloproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M5134", "name"=>"Bone Marrow Diseases", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T3995", "name"=>"Myeloid Leukemia", "asFound"=>"Myelogenous Leukemia", "relevance"=>"HIGH"}, {"id"=>"T1309", "name"=>"Chronic Myeloid Leukemia", "asFound"=>"Chronic myelogenous leukemia", "relevance"=>"HIGH"}, {"id"=>"T1311", "name"=>"Chronic Myeloproliferative Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D007372", "term"=>"Interferons"}, {"id"=>"D016898", "term"=>"Interferon-alpha"}, {"id"=>"D000077863", "term"=>"Homoharringtonine"}], "ancestors"=>[{"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D011500", "term"=>"Protein Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M2853", "name"=>"Immunomodulating Agents", "relevance"=>"LOW"}, {"id"=>"M10407", "name"=>"Interferons", "asFound"=>"Volunteers", "relevance"=>"HIGH"}, {"id"=>"M19243", "name"=>"Interferon-alpha", "asFound"=>"Cross-", "relevance"=>"HIGH"}, {"id"=>"M1920", "name"=>"Homoharringtonine", "asFound"=>"Pelvic lymph node dissection", "relevance"=>"HIGH"}, {"id"=>"M266317", "name"=>"Interferon-alfa-1b", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>87}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1994-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2001-10", "lastUpdateSubmitDate"=>"2013-02-04", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-08-09", "lastUpdatePostDateStruct"=>{"date"=>"2013-02-05", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-08-10", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2001-06", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["relapsing chronic myelogenous leukemia", "chronic phase chronic myelogenous leukemia"], "conditions"=>["Leukemia"]}, "descriptionModule"=>{"briefSummary"=>"Phase II trial to study the effectiveness of homoharringtonine and interferon alfa in treating patients with chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells.", "detailedDescription"=>"OBJECTIVES:\n\nI. Determine the efficacy of homoharringtonine administered simultaneously with interferon alpha in achieving complete cytogenetic response in patients with chronic myelogenous leukemia in chronic phase.\n\nOUTLINE:\n\nSingle-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"15 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\n* Chronic myelogenous leukemia (CML) in chronic phase\n* Clonal evolution (i.e., the presence of clones other than the Ph chromosome) allowed Ph chromosome variants or complex Ph chromosome translocations are not considered disease acceleration\n* Ineligible for known therapy of higher efficacy or priority\n* Allogeneic bone marrow transplantation should be considered priority therapy for CML patients with a matched related donor\n* No blastic phase CML (30% or more blasts in peripheral blood or bone marrow)\n* No accelerated phase CML, defined as any of the following: 15% or more peripheral or marrow blasts or 30% or more blasts and promyelocytes 20% or more peripheral or marrow basophils\n* Thrombocytopenia (platelets less than 100,000) unrelated to therapy\n* Documented extramedullary disease outside of liver or spleen\n\nPATIENT CHARACTERISTICS:\n\n* Age: 15 and over\n* Performance status: Zubrod 0-2\n* Life expectancy: Sufficient to fully evaluate the effects of 2 courses of therapy\n* Bilirubin no greater than 2.0 mg/dL\n* SGOT less than 300\n* Creatinine less than 2.0 mg/dL OR creatinine clearance at least 60 mL/min\n* No severe heart disease (class III/IV)\n* No pregnant or nursing women\n* Effective contraception required of fertile women\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior interferon alpha\n* At least 2 weeks since antileukemic therapy, with recovery required\n* Patients who received hydroxyurea within the past 2 weeks and have WBC greater than 50,000 may enter protocol after discussion with the primary investigator"}, "identificationModule"=>{"nctId"=>"NCT00002574", "briefTitle"=>"Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia", "organization"=>{"class"=>"NIH", "fullName"=>"National Cancer Institute (NCI)"}, "officialTitle"=>"PHASE II STUDY OF SIMULTANEOUS HOMOHARRINGTONINE (NSC 141633) AND ALPHA INTERFERON (IFN-A) THERAPY IN CHRONIC MYELOGENOUS LEUKEMIA (CML)", "orgStudyIdInfo"=>{"id"=>"NCI-2012-02233"}, "secondaryIdInfos"=>[{"id"=>"MDA-DM-93151"}, {"id"=>"NCI-T93-0191D"}, {"id"=>"CDR0000063647", "type"=>"REGISTRY", "domain"=>"PDQ (Physician Data Query)"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Arm I", "description"=>"Single-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523.", "interventionNames"=>["Biological: recombinant interferon alfa", "Drug: omacetaxine mepesuccinate"]}], "interventions"=>[{"name"=>"recombinant interferon alfa", "type"=>"BIOLOGICAL", "armGroupLabels"=>["Arm I"]}, {"name"=>"omacetaxine mepesuccinate", "type"=>"DRUG", "armGroupLabels"=>["Arm I"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"02115", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Dana-Farber Cancer Institute", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"University of Texas - MD Anderson Cancer Center", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}], "overallOfficials"=>[{"name"=>"Susan M. O'Brien, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"M.D. Anderson Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
