Nctid:
NCT00001209
Payload:
{"FullStudy"=>{"Rank"=>473707, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 01, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000012509", "ConditionMeshTerm"=>"Sarcoma"}, {"ConditionMeshId"=>"D000012516", "ConditionMeshTerm"=>"Osteosarcoma"}, {"ConditionMeshId"=>"D000017599", "ConditionMeshTerm"=>"Neuroectodermal Tumors"}, {"ConditionMeshId"=>"D000018242", "ConditionMeshTerm"=>"Neuroectodermal Tumors, Primitive"}, {"ConditionMeshId"=>"D000012512", "ConditionMeshTerm"=>"Sarcoma, Ewing"}, {"ConditionMeshId"=>"D000018241", "ConditionMeshTerm"=>"Neuroectodermal Tumors, Primitive, Peripheral"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000018204", "ConditionAncestorTerm"=>"Neoplasms, Connective and Soft Tissue"}, {"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000018213", "ConditionAncestorTerm"=>"Neoplasms, Bone Tissue"}, {"ConditionAncestorId"=>"D000009372", "ConditionAncestorTerm"=>"Neoplasms, Connective Tissue"}, {"ConditionAncestorId"=>"D000009373", "ConditionAncestorTerm"=>"Neoplasms, Germ Cell and Embryonal"}, {"ConditionAncestorId"=>"D000009380", "ConditionAncestorTerm"=>"Neoplasms, Nerve Tissue"}, {"ConditionAncestorId"=>"D000018302", "ConditionAncestorTerm"=>"Neoplasms, Neuroepithelial"}, {"ConditionAncestorId"=>"D000009375", "ConditionAncestorTerm"=>"Neoplasms, Glandular and Epithelial"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M15017", "ConditionBrowseLeafName"=>"Sarcoma", "ConditionBrowseLeafAsFound"=>"Sarcoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M15024", "ConditionBrowseLeafName"=>"Osteosarcoma", "ConditionBrowseLeafAsFound"=>"Osteosarcoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M15020", "ConditionBrowseLeafName"=>"Sarcoma, Ewing", "ConditionBrowseLeafAsFound"=>"Sarcoma, Ewing", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M19535", "ConditionBrowseLeafName"=>"Neuroectodermal Tumors", "ConditionBrowseLeafAsFound"=>"Neuroectodermal tumor", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M20078", "ConditionBrowseLeafName"=>"Neuroectodermal Tumors, Primitive", "ConditionBrowseLeafAsFound"=>"Neuroectodermal tumor", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M20077", "ConditionBrowseLeafName"=>"Neuroectodermal Tumors, Primitive, Peripheral", "ConditionBrowseLeafAsFound"=>"Sarcoma, Ewing", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M20040", "ConditionBrowseLeafName"=>"Neoplasms, Connective and Soft Tissue", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12005", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M20049", "ConditionBrowseLeafName"=>"Neoplasms, Bone Tissue", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12007", "ConditionBrowseLeafName"=>"Neoplasms, Connective Tissue", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12008", "ConditionBrowseLeafName"=>"Neoplasms, Germ Cell and Embryonal", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12015", "ConditionBrowseLeafName"=>"Neoplasms, Nerve Tissue", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M20136", "ConditionBrowseLeafName"=>"Neoplasms, Neuroepithelial", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12010", "ConditionBrowseLeafName"=>"Neoplasms, Glandular and Epithelial", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T5284", "ConditionBrowseLeafName"=>"Soft Tissue Sarcoma", "ConditionBrowseLeafAsFound"=>"Sarcoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T4340", "ConditionBrowseLeafName"=>"Osteosarcoma", "ConditionBrowseLeafAsFound"=>"Osteosarcoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T2148", "ConditionBrowseLeafName"=>"Ewing Sarcoma", "ConditionBrowseLeafAsFound"=>"Sarcoma, Ewing", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T4092", "ConditionBrowseLeafName"=>"Neuroepithelioma", "ConditionBrowseLeafAsFound"=>"Neuroectodermal tumor", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Skin and Connective Tissue Diseases", "ConditionBrowseBranchAbbrev"=>"BC17"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000003520", "InterventionMeshTerm"=>"Cyclophosphamide"}, {"InterventionMeshId"=>"D000007069", "InterventionMeshTerm"=>"Ifosfamide"}, {"InterventionMeshId"=>"D000014750", "InterventionMeshTerm"=>"Vincristine"}, {"InterventionMeshId"=>"D000004317", "InterventionMeshTerm"=>"Doxorubicin"}, {"InterventionMeshId"=>"C000506643", "InterventionMeshTerm"=>"Liposomal doxorubicin"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000007166", "InterventionAncestorTerm"=>"Immunosuppressive Agents"}, {"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000018501", "InterventionAncestorTerm"=>"Antirheumatic Agents"}, {"InterventionAncestorId"=>"D000018906", "InterventionAncestorTerm"=>"Antineoplastic Agents, Alkylating"}, {"InterventionAncestorId"=>"D000000477", "InterventionAncestorTerm"=>"Alkylating Agents"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000019653", "InterventionAncestorTerm"=>"Myeloablative Agonists"}, {"InterventionAncestorId"=>"D000000972", "InterventionAncestorTerm"=>"Antineoplastic Agents, Phytogenic"}, {"InterventionAncestorId"=>"D000050257", "InterventionAncestorTerm"=>"Tubulin Modulators"}, {"InterventionAncestorId"=>"D000050256", "InterventionAncestorTerm"=>"Antimitotic Agents"}, {"InterventionAncestorId"=>"D000050258", "InterventionAncestorTerm"=>"Mitosis Modulators"}, {"InterventionAncestorId"=>"D000000903", "InterventionAncestorTerm"=>"Antibiotics, Antineoplastic"}, {"InterventionAncestorId"=>"D000059005", "InterventionAncestorTerm"=>"Topoisomerase II Inhibitors"}, {"InterventionAncestorId"=>"D000059003", "InterventionAncestorTerm"=>"Topoisomerase Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M6417", "InterventionBrowseLeafName"=>"Cyclophosphamide", "InterventionBrowseLeafAsFound"=>"Take", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M7881", "InterventionBrowseLeafName"=>"Etoposide", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17185", "InterventionBrowseLeafName"=>"Vincristine", "InterventionBrowseLeafAsFound"=>"Postoperative", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M341584", "InterventionBrowseLeafName"=>"Etoposide phosphate", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9807", "InterventionBrowseLeafName"=>"Ifosfamide", "InterventionBrowseLeafAsFound"=>"Fiber", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M230774", "InterventionBrowseLeafName"=>"Isophosphamide mustard", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7182", "InterventionBrowseLeafName"=>"Doxorubicin", "InterventionBrowseLeafAsFound"=>"Antibody", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M227283", "InterventionBrowseLeafName"=>"Liposomal doxorubicin", "InterventionBrowseLeafAsFound"=>"Antibody", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M9902", "InterventionBrowseLeafName"=>"Immunosuppressive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9891", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20294", "InterventionBrowseLeafName"=>"Antirheumatic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20632", "InterventionBrowseLeafName"=>"Antineoplastic Agents, Alkylating", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3510", "InterventionBrowseLeafName"=>"Alkylating Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M25887", "InterventionBrowseLeafName"=>"Tubulin Modulators", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M25886", "InterventionBrowseLeafName"=>"Antimitotic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3912", "InterventionBrowseLeafName"=>"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3914", "InterventionBrowseLeafName"=>"Antibiotics, Antitubercular", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"Antirheumatic Agents", "InterventionBrowseBranchAbbrev"=>"ARhu"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"120"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"October 1986"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"September 1999", "CompletionDateStruct"=>{"CompletionDate"=>"August 2000"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"December 9, 2002", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"December 10, 2002", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Combined Chemotherapy", "Irradiation", "Unresectable"]}, "ConditionList"=>{"Condition"=>["Neuroectodermal Tumor, Primitive", "Neuroepithelioma", "Osteosarcoma", "Sarcoma", "Sarcoma, Ewing's"]}}, "DescriptionModule"=>{"BriefSummary"=>"This protocol is designed to test the feasibility of the administration of vincristine, adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide VP-16 as well as the efficacy of this therapy in addition to radiotherapy in producing complete responses and disease-free survival in patients with Ewing's sarcoma, primitive sarcoma of bone, peripheral neuroepithelioma, and soft tissue sarcoma. This will not be a randomized study but will be comparable to the large data base of similar patients treated on successive Pediatric Branch studies.", "DetailedDescription"=>"This protocol is designed to test the feasibility of the administration of vincristine, adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide VP-16 as well as the efficacy of this therapy in addition to radiotherapy in producing complete responses and disease-free survival in patients with Ewing's sarcoma, primitive sarcoma of bone, peripheral neuroepithelioma, and soft tissue sarcoma. This will not be a randomized study but will be comparable to the large data base of similar patients treated on successive Pediatric Branch studies."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Patients with high grade soft tissue sarcomas and either metastatic disease or stage III tumors including synovial sarcoma, malignant fibrous histiocytoma, hemangiopericytoma, malignant schwannoma (neurofibrosarcoma).\n\nPatients must not have been previously treated with chemotherapy or radiation therapy.\n\nThe patients age must be less than or equal to 25 years.\n\nThe patient (or their guardian if under 18 years of age) must sign a document indicating that he/she is aware of the investigational nature of this treatment protocol and the potential risks and benefits that may be expected.\n\nPatients must have a direct bilirubin of less than 4.0 mg/dl.\n\nPatients must not have abnormal cardiac function (ejection fraction greater than 45% on MUGA scan with confirmation of shortening-fraction greater than 25% on echocardiography)."}, "IdentificationModule"=>{"NCTId"=>"NCT00001209", "BriefTitle"=>"A Pilot Study for the Treatment of Patients With Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Pilot Study for the Treatment of Patients With Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors", "OrgStudyIdInfo"=>{"OrgStudyId"=>"860169"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"86-C-0169"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"vincristine, adriamycin and cytoxan, alternating with ifosfamide VP-16", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Cancer Institute (NCI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Cancer Institute (NCI)", "LeadSponsorClass"=>"NIH"}}}}}}