Nctid:
NCT00002554
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27", "removedCountries"=>["United States"]}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007938", "term"=>"Leukemia"}, {"id"=>"D007951", "term"=>"Leukemia, Myeloid"}, {"id"=>"D015470", "term"=>"Leukemia, Myeloid, Acute"}], "ancestors"=>[{"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D006402", "term"=>"Hematologic Diseases"}], "browseLeaves"=>[{"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M10945", "name"=>"Leukemia", "asFound"=>"Leukemia", "relevance"=>"HIGH"}, {"id"=>"M10955", "name"=>"Leukemia, Myeloid", "asFound"=>"Myelogenous Leukemia", "relevance"=>"HIGH"}, {"id"=>"M18127", "name"=>"Leukemia, Myeloid, Acute", "asFound"=>"Acute Myelogenous Leukemia", "relevance"=>"HIGH"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T3995", "name"=>"Myeloid Leukemia", "asFound"=>"Myelogenous Leukemia", "relevance"=>"HIGH"}, {"id"=>"T182", "name"=>"Acute Myeloid Leukemia", "asFound"=>"Acute Myelogenous Leukemia", "relevance"=>"HIGH"}, {"id"=>"T188", "name"=>"Acute Non Lymphoblastic Leukemia", "asFound"=>"Acute Myelogenous Leukemia", "relevance"=>"HIGH"}], "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"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D003520", "term"=>"Cyclophosphamide"}, {"id"=>"D002066", "term"=>"Busulfan"}, {"id"=>"D008727", "term"=>"Methotrexate"}], "ancestors"=>[{"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000477", "term"=>"Alkylating Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D019653", "term"=>"Myeloablative Agonists"}, {"id"=>"D000020", "term"=>"Abortifacient Agents, Nonsteroidal"}, {"id"=>"D000019", "term"=>"Abortifacient Agents"}, {"id"=>"D012102", "term"=>"Reproductive Control Agents"}, {"id"=>"D000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D003879", "term"=>"Dermatologic Agents"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D005493", "term"=>"Folic Acid Antagonists"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}], "browseLeaves"=>[{"id"=>"M4225", "name"=>"Antibodies", "relevance"=>"LOW"}, {"id"=>"M4230", "name"=>"Antibodies, Monoclonal", "relevance"=>"LOW"}, {"id"=>"M10184", "name"=>"Immunoglobulins", "relevance"=>"LOW"}, {"id"=>"M6727", "name"=>"Cyclophosphamide", "asFound"=>"Was", "relevance"=>"HIGH"}, {"id"=>"M11703", "name"=>"Methotrexate", "asFound"=>"Positive", "relevance"=>"HIGH"}, {"id"=>"M5336", "name"=>"Busulfan", "asFound"=>"Ischemic", "relevance"=>"HIGH"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M7074", "name"=>"Dermatologic Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M8619", "name"=>"Folic Acid Antagonists", "relevance"=>"LOW"}, {"id"=>"T447", "name"=>"Folinic Acid", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1993-11"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2010-03", "completionDateStruct"=>{"date"=>"1999-12", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2010-03-29", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2010-03-30", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-08-31", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1999-12", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["recurrent adult acute myeloid leukemia", "adult acute myeloid leukemia in remission"], "conditions"=>["Leukemia"]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Monoclonal antibody combined with a radioactive substance and given prior to bone marrow transplantation may kill more cancer cells.\n\nPURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody given prior to bone marrow transplantation in treating patients with acute myelogenous leukemia.", "detailedDescription"=>"OBJECTIVES: I. Determine the overall and disease-free survival and toxicity associated with busulfan/cyclophosphamide (BU/CTX) plus 131I-labeled BC8 antibody (131I-BC8) followed by an HLA-identical related marrow transplant in patients with acute myelogenous leukemia in first or second remission or untreated first relapse. II. Study factors that may influence the biodistribution of 131I-BC8 in this patient population, including marrow cellularity, the level of antigen expression by leukemic cells (in relapsed patients), and the degree of antigen saturation by antibody. III. Determine the efficacy of BU/CTX in patients in first remission unable to receive radiolabeled antibody, e.g., patients who are HAMA-positive, those not tolerating antibody test infusion, those with unfavorable antibody biodistribution, or those for whom antibody is unavailable.\n\nOUTLINE: Radioimmunotherapy plus 2-Drug Cytoreductive Chemotherapy followed by Bone Marrow Transplantation with, as indicated, CNS Therapy. Iodine-131-labeled Monoclonal Antibody BC8 (anti-CD45), 131I-BC8; plus Busulfan, BU, NSC-750; Cyclophosphamide, CTX, NSC-26271; followed by Allogeneic Bone Marrow, ABM; with, as indicated, Intrathecal Methotrexate, IT MTX, NSC-740.\n\nPROJECTED ACCRUAL: It is anticipated that 30 patients in first remission, 30 patients in untreated first relapse, and 15 patients in second remission will be accrued over 3 years."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"55 years", "minimumAge"=>"16 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Acute myelogenous leukemia in first or second remission or untreated first relapse Documented CD45 expression by leukemic cells required for patients in relapse Phenotyping not required for patients in remission; such patients may have leukemia previously documented to be CD45 negative Circulating blast count less than 10,000 (control with hydroxyurea or similar agent allowed) Genotypically or phenotypically HLA-matched related marrow donor required No donors mismatched for 1 or more HLA antigens No psychologic, physiologic, or medical contraindication to donation No high risk for anesthesia because of age or medical problems No HIV seropositive donors\n\nPATIENT CHARACTERISTICS: Age: 16 to 55 Performance status: Not specified Life expectancy: Greater than 60 days Hematopoietic: Not applicable Hepatic: Bilirubin less than 1.5 mg/dl No risk of developing veno-occlusive disease of the liver (i.e., current evidence of hepatitis as manifested by SGOT greater than 1.5 x ULN) Renal: Creatinine less than 2.0 mg/dl Other: No HIV seropositivity No major infection\n\nPRIOR CONCURRENT THERAPY: See Disease Characteristics No prior radiotherapy to maximally tolerated levels for any normal organ"}, "identificationModule"=>{"nctId"=>"NCT00002554", "briefTitle"=>"Monoclonal Antibody Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia in Remission or First Relapse", "organization"=>{"class"=>"OTHER", "fullName"=>"Fred Hutchinson Cancer Center"}, "officialTitle"=>"RADIOLABELED BC8 (ANTI-CD45) ANTIBODY COMBINED WITH BUSULFAN AND CYCLOPHOSPHAMIDE AS TREATMENT FOR ACUTE MYELOGENOUS LEUKEMIA IN FIRST OR SECOND REMISSION OR UNTREATED FIRST RELAPSE FOLLOWED BY HLA-IDENTICAL RELATED MARROW TRANSPLANTATION", "orgStudyIdInfo"=>{"id"=>"832.00"}, "secondaryIdInfos"=>[{"id"=>"CDR0000063421", "type"=>"REGISTRY", "domain"=>"PDQ"}, {"id"=>"NCI-V94-0393"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"busulfan", "type"=>"DRUG"}, {"name"=>"cyclophosphamide", "type"=>"DRUG"}, {"name"=>"methotrexate", "type"=>"DRUG"}, {"name"=>"allogeneic bone marrow transplantation", "type"=>"PROCEDURE"}, {"name"=>"radioimmunotherapy", "type"=>"RADIATION"}]}, "contactsLocationsModule"=>{"overallOfficials"=>[{"name"=>"John Pagel, MD, PhD", "role"=>"STUDY_CHAIR", "affiliation"=>"Fred Hutchinson Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fred Hutchinson Cancer Center", "class"=>"OTHER"}}}}
