Nctid:
NCT00002543
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008223", "term"=>"Lymphoma"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D009447", "term"=>"Neuroblastoma"}, {"id"=>"D012208", "term"=>"Rhabdomyosarcoma"}, {"id"=>"D009423", "term"=>"Nervous System Neoplasms"}, {"id"=>"D016543", "term"=>"Central Nervous System Neoplasms"}], "ancestors"=>[{"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D012509", "term"=>"Sarcoma"}, {"id"=>"D018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D018241", "term"=>"Neuroectodermal Tumors, Primitive, Peripheral"}, {"id"=>"D018242", "term"=>"Neuroectodermal Tumors, Primitive"}, {"id"=>"D018302", "term"=>"Neoplasms, Neuroepithelial"}, {"id"=>"D017599", "term"=>"Neuroectodermal Tumors"}, {"id"=>"D009373", "term"=>"Neoplasms, Germ Cell and Embryonal"}, {"id"=>"D009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D009380", "term"=>"Neoplasms, Nerve Tissue"}, {"id"=>"D009217", "term"=>"Myosarcoma"}, {"id"=>"D009379", "term"=>"Neoplasms, Muscle Tissue"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M11220", "name"=>"Lymphoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M15327", "name"=>"Sarcoma", "relevance"=>"LOW"}, {"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M12367", "name"=>"Nervous System Neoplasms", "asFound"=>"Nervous System Tumors", "relevance"=>"HIGH"}, {"id"=>"M18937", "name"=>"Central Nervous System Neoplasms", "asFound"=>"Central Nervous System Tumors", "relevance"=>"HIGH"}, {"id"=>"M27585", "name"=>"Precursor Cell Lymphoblastic Leukemia-Lymphoma", "relevance"=>"LOW"}, {"id"=>"M5209", "name"=>"Brain Neoplasms", "relevance"=>"LOW"}, {"id"=>"M12391", "name"=>"Neuroblastoma", "asFound"=>"Neuroblastoma", "relevance"=>"HIGH"}, {"id"=>"M15037", "name"=>"Rhabdomyosarcoma", "asFound"=>"Rhabdomyosarcoma", "relevance"=>"HIGH"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M11225", "name"=>"Lymphoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M11203", "name"=>"Lymphatic Diseases", "relevance"=>"LOW"}, {"id"=>"M10206", "name"=>"Immunoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M20350", "name"=>"Neoplasms, Connective and Soft Tissue", "relevance"=>"LOW"}, {"id"=>"M20387", "name"=>"Neuroectodermal Tumors, Primitive, Peripheral", "relevance"=>"LOW"}, {"id"=>"M19845", "name"=>"Neuroectodermal Tumors", "relevance"=>"LOW"}, {"id"=>"M20388", "name"=>"Neuroectodermal Tumors, Primitive", "relevance"=>"LOW"}, {"id"=>"M20446", "name"=>"Neoplasms, Neuroepithelial", "relevance"=>"LOW"}, {"id"=>"M12318", "name"=>"Neoplasms, Germ Cell and Embryonal", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12325", "name"=>"Neoplasms, Nerve Tissue", "relevance"=>"LOW"}, {"id"=>"M12169", "name"=>"Myosarcoma", "relevance"=>"LOW"}, {"id"=>"T3543", "name"=>"Lymphosarcoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T5284", "name"=>"Soft Tissue Sarcoma", "relevance"=>"LOW"}, {"id"=>"T175", "name"=>"Acute Lymphoblastic Leukemia", "relevance"=>"LOW"}, {"id"=>"T3533", "name"=>"Lymphoblastic Lymphoma", "relevance"=>"LOW"}, {"id"=>"T4085", "name"=>"Neuroblastoma", "asFound"=>"Neuroblastoma", "relevance"=>"HIGH"}, {"id"=>"T852", "name"=>"Brain Tumor, Childhood", "relevance"=>"LOW"}, {"id"=>"T4092", "name"=>"Neuroepithelioma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C027235", "term"=>"Gallium nitrate"}], "ancestors"=>[{"id"=>"D000077264", "term"=>"Calcium-Regulating Hormones and Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}], "browseLeaves"=>[{"id"=>"M257395", "name"=>"Gallium nitrate", "asFound"=>"HDM201", "relevance"=>"HIGH"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M5381", "name"=>"Calcium", "relevance"=>"LOW"}, {"id"=>"M5398", "name"=>"Calcium, Dietary", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>3}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-02"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2007-05", "completionDateStruct"=>{"date"=>"2004-10", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-07-17", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-10-04", "lastUpdatePostDateStruct"=>{"date"=>"2013-07-18", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-10-05", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["recurrent childhood rhabdomyosarcoma", "recurrent childhood brain tumor", "recurrent neuroblastoma", "recurrent childhood lymphoblastic lymphoma", "unspecified childhood solid tumor, protocol specific", "recurrent childhood small noncleaved cell lymphoma", "recurrent childhood large cell lymphoma"], "conditions"=>["Brain and Central Nervous System Tumors", "Lymphoma", "Neuroblastoma", "Sarcoma", "Unspecified Childhood Solid Tumor, Protocol Specific"]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: : Phase I trial to study the effectiveness of gallium nitrate in young patients who have malignant brain tumors, neuroblastoma, rhabdomyosarcoma, non-Hodgkin's lymphoma, or refractory solid tumor.", "detailedDescription"=>"OBJECTIVES: I. Determine the safety and side effects of gallium nitrate (GAN) when used as an anticancer agent in pediatric patients with refractory solid tumors, including malignant brain tumors, neuroblastoma, rhabdomyosarcoma, and non-Hodgkin's lymphoma. II. Evaluate these side effects in these patients.\n\nOUTLINE: Single-Agent Chemotherapy. Gallium Nitrate, GAN, NSC-15200.\n\nPROJECTED ACCRUAL: At least 3 patients will be accrued at each dose studied."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"21 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Biopsy-proven rhabdomyosarcoma, non-Hodgkin's lymphoma, or other solid tumor refractory to conventional therapy or for which no effective curative therapy is known Re-biopsy required if disease recurs more than 2 years after initial diagnosis recommended if radiographic abnormalities suggest tumor recurrence within 5 months of completing radiotherapy or chemotherapy\n\nPATIENT CHARACTERISTICS: Age: 21 and under at diagnosis Performance status: Karnofsky 50%-100% Life expectancy: More than 4 weeks Hematopoietic: (unless extensive bone marrow involvement) ANC greater than 750 Platelets greater than 75,000 Hepatic: Not specified Renal: Creatinine normal for age OR Glomerular filtration rate at least 50 mL/min per 1.73 square meters Other: Adequate nutritional status No serious uncontrolled infection No pregnant or nursing women\n\nPRIOR CONCURRENT THERAPY: At least 2 weeks since other anticancer therapy and recovered Prior radiotherapy or surgery for symptomatic lesions allowed provided site of evaluable disease remains untreated Prior bone marrow or stem cell transplantation allowed No concurrent anticancer therapy"}, "identificationModule"=>{"nctId"=>"NCT00002543", "briefTitle"=>"Gallium Nitrate in Treating Children With Brain Tumor, Neuroblastoma, Rhabdomyosarcoma, Non-Hodgkin's Lymphoma, or Refractory Solid Tumors", "organization"=>{"class"=>"NIH", "fullName"=>"National Cancer Institute (NCI)"}, "officialTitle"=>"GALLIUM NITRATE FOR THE TREATMENT OF MALIGNANT TUMORS, A PHASE I STUDY", "orgStudyIdInfo"=>{"id"=>"MCW-ARRC-22393"}, "secondaryIdInfos"=>[{"id"=>"CDR0000063244", "type"=>"REGISTRY", "domain"=>"PDQ (Physician Data Query)"}, {"id"=>"CHW-93/59"}, {"id"=>"NCI-T93-0097D"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"gallium nitrate", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"21201", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Marlene & Stewart Greenebaum Cancer Center, University of Maryland", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"02111", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Boston Floating Hospital Infants and Children", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"53226", "city"=>"Milwaukee", "state"=>"Wisconsin", "country"=>"United States", "facility"=>"Medical College of Wisconsin", "geoPoint"=>{"lat"=>43.0389, "lon"=>-87.90647}}], "overallOfficials"=>[{"name"=>"Harry T. Whelan, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Medical College of Wisconsin"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Medical College of Wisconsin", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}]}}}
