Nctid:
NCT00001805
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D001943", "term"=>"Breast Neoplasms"}, {"id"=>"D008175", "term"=>"Lung Neoplasms"}, {"id"=>"D010190", "term"=>"Pancreatic Neoplasms"}, {"id"=>"D013274", "term"=>"Stomach Neoplasms"}, {"id"=>"D003110", "term"=>"Colonic Neoplasms"}], "ancestors"=>[{"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D001941", "term"=>"Breast Diseases"}, {"id"=>"D012871", "term"=>"Skin Diseases"}, {"id"=>"D012142", "term"=>"Respiratory Tract Neoplasms"}, {"id"=>"D013899", "term"=>"Thoracic Neoplasms"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D004701", "term"=>"Endocrine Gland Neoplasms"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D010182", "term"=>"Pancreatic Diseases"}, {"id"=>"D004700", "term"=>"Endocrine System Diseases"}, {"id"=>"D005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D013272", "term"=>"Stomach Diseases"}, {"id"=>"D015179", "term"=>"Colorectal Neoplasms"}, {"id"=>"D007414", "term"=>"Intestinal Neoplasms"}, {"id"=>"D003108", "term"=>"Colonic Diseases"}, {"id"=>"D007410", "term"=>"Intestinal Diseases"}], "browseLeaves"=>[{"id"=>"M5220", "name"=>"Breast Neoplasms", "asFound"=>"Breast Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M6338", "name"=>"Colonic Neoplasms", "asFound"=>"Colonic Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M11172", "name"=>"Lung Neoplasms", "asFound"=>"Lung Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M13110", "name"=>"Pancreatic Neoplasms", "asFound"=>"Pancreatic Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M16064", "name"=>"Stomach Neoplasms", "asFound"=>"Stomach Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M5218", "name"=>"Breast Diseases", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M14979", "name"=>"Respiratory Tract Neoplasms", "relevance"=>"LOW"}, {"id"=>"M16658", "name"=>"Thoracic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7863", "name"=>"Endocrine Gland Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M13102", "name"=>"Pancreatic Diseases", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"M16062", "name"=>"Stomach Diseases", "relevance"=>"LOW"}, {"id"=>"M17890", "name"=>"Colorectal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M10448", "name"=>"Intestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M6336", "name"=>"Colonic Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"T4387", "name"=>"Pancreatic Cancer", "asFound"=>"Pancreatic Neoplasms", "relevance"=>"HIGH"}, {"id"=>"T5486", "name"=>"Stomach Cancer", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000069283", "term"=>"Rituximab"}], "ancestors"=>[{"id"=>"D000074322", "term"=>"Antineoplastic Agents, Immunological"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}], "browseLeaves"=>[{"id"=>"M373", "name"=>"Rituximab", "asFound"=>"Pain", "relevance"=>"HIGH"}, {"id"=>"M4225", "name"=>"Antibodies", "relevance"=>"LOW"}, {"id"=>"M10184", "name"=>"Immunoglobulins", "relevance"=>"LOW"}, {"id"=>"M4308", "name"=>"Antitoxins", "relevance"=>"LOW"}, {"id"=>"M4241", "name"=>"Immunotoxins", "relevance"=>"LOW"}, {"id"=>"M1346", "name"=>"Antineoplastic Agents, Immunological", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"T120", "name"=>"Cola", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Herbal and Botanical", "abbrev"=>"HB"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>20}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1999-03"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-03", "completionDateStruct"=>{"date"=>"2000-06"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Breast Cancer", "Colon Cancer", "Gastric Cancer", "Lung Cancer", "Pancreatic Cancer"], "conditions"=>["Breast Neoplasms", "Colonic Neoplasms", "Lung Neoplasms", "Pancreatic Neoplasms", "Stomach Neoplasms"]}, "referencesModule"=>{"references"=>[{"pmid"=>"7683045", "type"=>"BACKGROUND", "citation"=>"Grossbard ML, Lambert JM, Goldmacher VS, Spector NL, Kinsella J, Eliseo L, Coral F, Taylor JA, Blattler WA, Epstein CL, et al. Anti-B4-blocked ricin: a phase I trial of 7-day continuous infusion in patients with B-cell neoplasms. J Clin Oncol. 1993 Apr;11(4):726-37. doi: 10.1200/JCO.1993.11.4.726."}, {"pmid"=>"8219217", "type"=>"BACKGROUND", "citation"=>"Amlot PL, Stone MJ, Cunningham D, Fay J, Newman J, Collins R, May R, McCarthy M, Richardson J, Ghetie V, et al. A phase I study of an anti-CD22-deglycosylated ricin A chain immunotoxin in the treatment of B-cell lymphomas resistant to conventional therapy. Blood. 1993 Nov 1;82(9):2624-33."}, {"pmid"=>"2790828", "type"=>"BACKGROUND", "citation"=>"Byers VS, Rodvien R, Grant K, Durrant LG, Hudson KH, Baldwin RW, Scannon PJ. Phase I study of monoclonal antibody-ricin A chain immunotoxin XomaZyme-791 in patients with metastatic colon cancer. Cancer Res. 1989 Nov 1;49(21):6153-60."}]}, "descriptionModule"=>{"briefSummary"=>"This is a phase II clinical and pharmacokinetic study of suppression of human antimouse (HAMA) and antitoxin antibodies (HATA) to immunotoxin LMB-1 by Rituximab (anti-CD20). The primary objective of this study is to determine the effect of Rituximab on HAMA and HATA response to LMB-1 administered to patients with advanced carcinoma that express the B3 antigen. Other objectives include evaluation of the pharmacokinetics and anti-tumor effects.", "detailedDescription"=>"This is a phase II clinical and pharmacokinetic study of suppression of human antimouse (HAMA) and antitoxin antibodies (HATA) to immunotoxin LMB-1 by Rituximab (anti-CD20). The primary objective of this study is to determine the effect of Rituximab on HAMA and HATA response to LMB-1 administered to patients with advanced carcinoma that express the B3 antigen. Other objectives include evaluation of the pharmacokinetics and anti-tumor effects."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Patients must have advanced stage solid tumor with histologically or cytologically proven evaluable or measurable disease and who are refractory to standard treatment for their malignancy or for whom no effective standard therapy exists.\n\nMust have the presence of B3 antigen on the surface of greater than 30% of the tumor cells.\n\nMust be greater than or equal to 18 years old and be able to give informed consent.\n\nMust have an ECOG performance status of 0 or 1 and a minimum life expectancy of 3 months.\n\nMust have normal renal function (Creatinine less than or equal to 1.4 mg/dl), SGOT and SGPT less than or equal to 2.5 x of the upper limits of normal. Total bilirubin less than 1.5 mg/dL; AGC greater than or equal to 1.5 x 10(3) microliter; platelets greater than 100,000 per mm(3).\n\nMust have recovered from the toxic effects of prior chemotherapy or radiation therapy. At least 3 weeks must have elapsed since the last dose of chemotherapy, hormonal therapy or radiation therapy. At least six weeks must have elapsed since the last dose of Mitomycin C and a nitrosourea.\n\nMust not have serum neutralizing antibodies to LMB-1.\n\nMust not have positive hepatitis B surface antigen, hepatitis C antibody or HIV.\n\nMust not have a history of coronary artery disease, NY class II-IV CHF, arrhythmia requiring treatment and any contraindication to pressor therapy.\n\nMust not have FEV1 and FVC less than or equal to 65% of the predicted value.\n\nMust not have baseline serum albumin of less than 3.0 g/dl.\n\nMust not have a history of CNS metastasis and/or known seizure disorders, or concurrent malignancy.\n\nMust not have an acute bacterial infection that requires antibiotic therapy (unless infection is completely resolved).\n\nMust not have any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.\n\nMust not be pregnant or breastfeeding. Patients of childbearing potential must agree to use an effective method of contraception.\n\nMust not have a history of allergic reaction to penicillin.\n\nMust not have lymphoma."}, "identificationModule"=>{"nctId"=>"NCT00001805", "briefTitle"=>"A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab", "orgStudyIdInfo"=>{"id"=>"990071"}, "secondaryIdInfos"=>[{"id"=>"99-C-0071"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Rituximab", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Cancer Institute (NCI)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}}}}
