Nctid:
NCT00001300
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012509", "term"=>"Sarcoma"}], "ancestors"=>[{"id"=>"D018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}], "browseLeaves"=>[{"id"=>"M15327", "name"=>"Sarcoma", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"id"=>"M20350", "name"=>"Neoplasms, Connective and Soft Tissue", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"T5284", "name"=>"Soft Tissue Sarcoma", "asFound"=>"Soft Tissue Sarcoma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D004317", "term"=>"Doxorubicin"}, {"id"=>"D007069", "term"=>"Ifosfamide"}], "ancestors"=>[{"id"=>"D000903", "term"=>"Antibiotics, Antineoplastic"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D059005", "term"=>"Topoisomerase II Inhibitors"}, {"id"=>"D059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000477", "term"=>"Alkylating Agents"}], "browseLeaves"=>[{"id"=>"M7492", "name"=>"Doxorubicin", "asFound"=>"Treated", "relevance"=>"HIGH"}, {"id"=>"M227339", "name"=>"Liposomal doxorubicin", "relevance"=>"LOW"}, {"id"=>"M10117", "name"=>"Ifosfamide", "asFound"=>"Transfer", "relevance"=>"HIGH"}, {"id"=>"M230811", "name"=>"Isophosphamide mustard", "relevance"=>"LOW"}, {"id"=>"M17811", "name"=>"Mesna", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>150}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1992-06"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-04", "completionDateStruct"=>{"date"=>"2001-03"}, "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"=>["Adjuvant Chemotherapy", "Ifosfamide", "Randomized Study", "Soft Tissue Sarcoma"], "conditions"=>["Sarcoma"]}, "referencesModule"=>{"references"=>[{"pmid"=>"3566372", "type"=>"BACKGROUND", "citation"=>"Lawrence W Jr, Donegan WL, Natarajan N, Mettlin C, Beart R, Winchester D. Adult soft tissue sarcomas. A pattern of care survey of the American College of Surgeons. Ann Surg. 1987 Apr;205(4):349-59. doi: 10.1097/00000658-198704000-00003."}, {"pmid"=>"2674336", "type"=>"BACKGROUND", "citation"=>"Alvegard TA, Sigurdsson H, Mouridsen H, Solheim O, Unsgaard B, Ringborg U, Dahl O, Nordentoft AM, Blomqvist C, Rydholm A, et al. Adjuvant chemotherapy with doxorubicin in high-grade soft tissue sarcoma: a randomized trial of the Scandinavian Sarcoma Group. J Clin Oncol. 1989 Oct;7(10):1504-13. doi: 10.1200/JCO.1989.7.10.1504."}, {"pmid"=>"3047339", "type"=>"BACKGROUND", "citation"=>"Chang AE, Kinsella T, Glatstein E, Baker AR, Sindelar WF, Lotze MT, Danforth DN Jr, Sugarbaker PH, Lack EE, Steinberg SM, et al. Adjuvant chemotherapy for patients with high-grade soft-tissue sarcomas of the extremity. J Clin Oncol. 1988 Sep;6(9):1491-500. doi: 10.1200/JCO.1988.6.9.1491."}]}, "descriptionModule"=>{"briefSummary"=>"Randomized study. All patients must be randomized to treatment on Arms I and II within 3 months of definitive surgery on Regimen A.\n\nRegimen A: Surgery followed, as indicated, by Radiotherapy. Amputation; or limb-sparing resection followed by involved-field irradiation using megavoltage equipment with or without electron boost.\n\nArm I: 2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation and Urothelial Protection. Doxorubicin, DOX, NSC-123127; Ifosfamide, IFF, NSC-109724; with Granulocyte Colony Stimulating Factor (Amgen), G-CSF,\n\nNSC-614629; and Mesna, NSC-113891.\n\nArm II: Observation. No adjuvant chemotherapy.", "detailedDescription"=>"Patients with primary, high-grade soft tissue sarcoma of the extremities will undergo treatment of their primary tumor with either amputation or limb-sparing surgery and radiotherapy, and then be randomized to either observation or adjuvant treatment with doxorubicin and ifosfamide with mesna (with G-CSF) for five cycles beginning post-operatively. Local recurrence, disease-free survival and overall survival will be evaluated in this randomized two-arm trial."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nHistologically proven AR and ESFT which includes: Classical, atypical and extraosseous Ewing's sarcoma, primitive peripheral neuroectodermal tumors, peripheral neuroepithelioma, primitive sarcoma of bone, and ectomesenchymoma.\n\nConfirmed presence of tumor-specific infusion protein by documented RT-PCR which corresponds to one of the tumor specific peptides available for vaccination.\n\nMeasurable tumor.\n\nNo prior or current CNS metastases.\n\nPRIOR/CONCURRENT THERAPY:\n\nArm A patients:\n\nMay be enrolled on the protocol for the first phase in the absence of RT PCR documentation of a tumor-specific fusion protein which corresponds to one of the tumor-specific peptides available for vaccination. However, RT PCR documentation at the time of tumor recurrence must occur prior to administration of immunotherapy. At time of initial tumor diagnosis, prior to any cytoreductive therapy.\n\nArm B patients:\n\nTumor recurrence occurring during or after receiving at least first line cytoreductive therapy for ESFT and AR. No more than two post-recurrence salvage regimens unless peripheral CD4+T cell number is greater than 400 cells per millimeter cubed.\n\nAt least 6 weeks since any treatments and recovered from all acute toxic effects from time in which immunotherapy will be started for this study.\n\nNo concurrent estrogen therapy during immunotherapy section of study.\n\nPATIENT CHARACTERISTICS:\n\nAge: 2-25 (at time of initial diagnosis of alveolar rhabdomyosarcoma).\n\nWeight: Greater than 15 kg (at time of apheresis).\n\nPerformance status: ECOG 0-2.\n\nLife expectancy: At least 8 weeks.\n\nHematopoietic:\n\nANC greater than 100,000/mm3.\n\nHemoglobin greater than 9.0 g/dL.\n\nPlatelet count greater than 50,000/mm3.\n\nHepatic:\n\nBilirubin less than 2.0 mg/dL (unless related to involvement by tumor).\n\nTransaminases less than 3 times normal (unless related to involvement by tumor).\n\nRenal:\n\nCreatinine less than 1.5 mg/dL or creatinine clearance greater than 60 mL/min.\n\nCardiovascular:\n\nNo major disorder of cardiovascular system.\n\nCardiac ejection fraction greater than 40%.\n\nPulmonary:\n\nNo major disorder of pulmonary system.\n\nOther:\n\nNot pregnant or nursing.\n\nHIV negative.\n\nHepatitis B or C negative.\n\nNo patients requiring daily oral corticosteroid therapy.\n\nIf allergic to eggs, egg products, or thimerosal, or have a history of Guillain-Barre syndrome, ineligible to receive influenza vaccine."}, "identificationModule"=>{"nctId"=>"NCT00001300", "briefTitle"=>"A Randomized Study of the Effect of Adjuvant Chemotherapy With Doxorubicin and Ifosfamide With Mesna in the Treatment of High-Grade Adult Extremity Soft Tissue Sarcoma", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Randomized Study of the Effect of Adjuvant Chemotherapy With Doxorubicin and Ifosfamide With Mesna in the Treatment of High-Grade Adult Extremity Soft Tissue Sarcoma", "orgStudyIdInfo"=>{"id"=>"920210"}, "secondaryIdInfos"=>[{"id"=>"92-C-0210"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"doxorubicin", "type"=>"DRUG"}, {"name"=>"ifosfamide", "type"=>"DRUG"}, {"name"=>"mesna", "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"}}}}