Nctid:
NCT00001296
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008545", "term"=>"Melanoma"}, {"id"=>"D009336", "term"=>"Necrosis"}], "ancestors"=>[{"id"=>"D018358", "term"=>"Neuroendocrine Tumors"}, {"id"=>"D017599", "term"=>"Neuroectodermal Tumors"}, {"id"=>"D009373", "term"=>"Neoplasms, Germ Cell and Embryonal"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D009380", "term"=>"Neoplasms, Nerve Tissue"}, {"id"=>"D018326", "term"=>"Nevi and Melanomas"}, {"id"=>"D012878", "term"=>"Skin Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D012871", "term"=>"Skin Diseases"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M8464", "name"=>"Fever", "relevance"=>"LOW"}, {"id"=>"M2454", "name"=>"Hyperthermia", "relevance"=>"LOW"}, {"id"=>"M11528", "name"=>"Melanoma", "asFound"=>"Melanoma", "relevance"=>"HIGH"}, {"id"=>"M12284", "name"=>"Necrosis", "asFound"=>"Necrosis", "relevance"=>"HIGH"}, {"id"=>"M20495", "name"=>"Neuroendocrine Tumors", "relevance"=>"LOW"}, {"id"=>"M19845", "name"=>"Neuroectodermal Tumors", "relevance"=>"LOW"}, {"id"=>"M20388", "name"=>"Neuroectodermal Tumors, Primitive", "relevance"=>"LOW"}, {"id"=>"M12318", "name"=>"Neoplasms, Germ Cell and Embryonal", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M12325", "name"=>"Neoplasms, Nerve Tissue", "relevance"=>"LOW"}, {"id"=>"M20470", "name"=>"Nevi and Melanomas", "relevance"=>"LOW"}, {"id"=>"M12446", "name"=>"Nevus", "relevance"=>"LOW"}, {"id"=>"M12448", "name"=>"Nevus, Pigmented", "relevance"=>"LOW"}, {"id"=>"M15681", "name"=>"Skin Neoplasms", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"T4091", "name"=>"Neuroendocrine Tumor", "relevance"=>"LOW"}, {"id"=>"T4092", "name"=>"Neuroepithelioma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D007372", "term"=>"Interferons"}, {"id"=>"D007371", "term"=>"Interferon-gamma"}, {"id"=>"D008558", "term"=>"Melphalan"}], "ancestors"=>[{"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000477", "term"=>"Alkylating Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D019653", "term"=>"Myeloablative Agonists"}, {"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M10407", "name"=>"Interferons", "asFound"=>"Phase II", "relevance"=>"HIGH"}, {"id"=>"M10406", "name"=>"Interferon-gamma", "asFound"=>"Narrative", "relevance"=>"HIGH"}, {"id"=>"M11541", "name"=>"Melphalan", "asFound"=>"Experience", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>122}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1992-02"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-11", "completionDateStruct"=>{"date"=>"2000-10"}, "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"=>["Interferon-Gamma", "Isolated Limb Perfusion", "Melanoma", "Melphalan", "TNF"], "conditions"=>["Melanoma"]}, "referencesModule"=>{"references"=>[{"pmid"=>"7350699", "type"=>"BACKGROUND", "citation"=>"Karakousis CP, Choe KJ, Holyoke ED. Biologic behavior and treatment of intransit metastasis of melanoma. Surg Gynecol Obstet. 1980 Jan;150(1):29-32."}]}, "descriptionModule"=>{"briefSummary"=>"Randomized study. Initially, 3 patients will be entered on Arm I as a pilot feasibility study and to standardize the technical aspects of the study. Subsequently, all patients are randomized to Arms I and II.\n\nArm I: Regional Hyperthermia plus Regional Single-Agent Chemotherapy. Hyperthermic intravenous limb perfusion, HILP; plus Melphalan, L-PAM, NSC-8806.\n\nArm II: Regional Hyperthermia plus Regional Single-Agent Chemotherapy and Biological Response Modifier Therapy. HILP as in Arm I; plus L-PAM; and Tumor Necrosis Factor (Knoll), TNF, NSC-635257; Interferon gamma (Genentech), IFN-G, NSC-600662.", "detailedDescription"=>"Patients with locally advanced melanoma confined to an extremity (Stage IIIA or Stage IIIAB) will be treated in a randomized Phase III study with hyperthermic isolated limb perfusion. One arm of the study will be a standard 60 minute perfusion with melphalan as a single agent. The second arm of the study will combine melphalan, tumor necrosis factor, and interferon-gamma in the isolated limb perfusion reproducing a regimen shown to have 100% response rates in a Phase II European trial. Patients will be followed for local response rates, duration of response, treatment toxicity, and disease-free survival."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nBiopsy-proven Stage IIIA or IIIAB melanoma (M.D. Anderson staging system) of an extremity, as follows:\n\nAdvanced local disease indicated by 2 or more satellite or in-transit metastases.\n\nLower limb regional metastases must be distal to the apex of the femoral triangle except inguinal lymph node metastases.\n\nUpper limb regional metastases must be distal to the deltoid insertion except axillary lymph node metastases.\n\nNo evidence of systemic disease outside the involved extremity.\n\nRecurrent disease subsequent to prior successful limb perfusion allowed.\n\nBidimensional directly measurable dermal or subcutaneous lesion required.\n\nPRIOR/CONCURRENT THERAPY:\n\nNo prior isolated limb perfusion.\n\nBiologic Therapy: At least 1 month since Biologic Therapy.\n\nAt least 3 months since regional therapy of the extremity.\n\nChemotherapy: At least 1 month since chemotherap.y\n\nAt least 3 months since regional therapy of the extremity.\n\nEndocrine Therapy: Not specified.\n\nRadiotherapy: At least 1 month since radiotherapy.\n\nSurgery: Not specified.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nPerformance status: ECOG 0 or 1.\n\nHematopoietic: Platelets greater than 150,000.\n\nHepatic: Bilirubin less than 1.5 mg/dl; Coagulation profile normal.\n\nRenal: Creatinine less than 2.0 mg/dl.\n\nCardiovascular: No evidence of peripheral vascular disease, e.g.:\n\nNo history of claudication.\n\nOTHER:\n\nHIV negative.\n\nNo pregnant or nursing women."}, "identificationModule"=>{"nctId"=>"NCT00001296", "briefTitle"=>"A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma", "orgStudyIdInfo"=>{"id"=>"920105"}, "secondaryIdInfos"=>[{"id"=>"92-C-0105"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"melphalan", "type"=>"DRUG"}, {"name"=>"tumor necrosis factor", "type"=>"DRUG"}, {"name"=>"interferon-gamma", "type"=>"DRUG"}, {"name"=>"hyperthermic isolated limb perfusion", "type"=>"PROCEDURE"}]}, "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"}}}}
