Nctid:
NCT00001577
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008545", "term"=>"Melanoma"}, {"id"=>"D000012509", "term"=>"Sarcoma"}], "ancestors"=>[{"id"=>"D000018358", "term"=>"Neuroendocrine Tumors"}, {"id"=>"D000017599", "term"=>"Neuroectodermal Tumors"}, {"id"=>"D000009373", "term"=>"Neoplasms, Germ Cell and Embryonal"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000009380", "term"=>"Neoplasms, Nerve Tissue"}, {"id"=>"D000018326", "term"=>"Nevi and Melanomas"}, {"id"=>"D000012878", "term"=>"Skin Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000012871", "term"=>"Skin Diseases"}, {"id"=>"D000018204", "term"=>"Neoplasms, Connective and Soft Tissue"}], "browseLeaves"=>[{"id"=>"M15327", "name"=>"Sarcoma", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"id"=>"M11528", "name"=>"Melanoma", "asFound"=>"Melanoma", "relevance"=>"HIGH"}, {"id"=>"M8464", "name"=>"Fever", "relevance"=>"LOW"}, {"id"=>"M2454", "name"=>"Hyperthermia", "relevance"=>"LOW"}, {"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"=>"M20350", "name"=>"Neoplasms, Connective and Soft Tissue", "relevance"=>"LOW"}, {"id"=>"T5284", "name"=>"Soft Tissue Sarcoma", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"id"=>"T4091", "name"=>"Neuroendocrine Tumor", "relevance"=>"LOW"}, {"id"=>"T4092", "name"=>"Neuroepithelioma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000008558", "term"=>"Melphalan"}], "ancestors"=>[{"id"=>"D000018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000000477", "term"=>"Alkylating Agents"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000019653", "term"=>"Myeloablative Agonists"}, {"id"=>"D000007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D000007155", "term"=>"Immunologic Factors"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M11541", "name"=>"Melphalan", "asFound"=>"Vein", "relevance"=>"HIGH"}, {"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"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>30}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1997-06"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-04", "completionDateStruct"=>{"date"=>"2000-03"}, "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"=>["Chemotherapy", "Hyperthermia", "Isolation perfusion", "Regional Therapy"], "conditions"=>["Melanoma", "Sarcoma"]}, "referencesModule"=>{"references"=>[{"pmid"=>"7799030", "type"=>"BACKGROUND", "citation"=>"Thom AK, Alexander HR, Andrich MP, Barker WC, Rosenberg SA, Fraker DL. Cytokine levels and systemic toxicity in patients undergoing isolated limb perfusion with high-dose tumor necrosis factor, interferon gamma, and melphalan. J Clin Oncol. 1995 Jan;13(1):264-73. doi: 10.1200/JCO.1995.13.1.264."}, {"pmid"=>"8914206", "type"=>"BACKGROUND", "citation"=>"Alexander HR Jr, Fraker DL, Bartlett DL. Isolated limb perfusion for malignant melanoma. Semin Surg Oncol. 1996 Nov-Dec;12(6):416-28. doi: 10.1002/(SICI)1098-2388(199611/12)12:63.0.CO;2-D."}]}, "descriptionModule"=>{"briefSummary"=>"Hyperthermic isolated limb perfusion with melphalan alone is administered as a double perfusion schedule.\n\nThese two isolates limb perfusions with melphalan are treated 3-6 weeks apart. After perfusion is established, the leak rate has been determined to be acceptable, and tissue temperatures are 38 degrees Celsius, then the melphalan is administered by slow injection into an arterial line over approximately 5 minutes. The perfusion with melphalan will then continue for 60 minutes, after which the extremity is flushed out with a total of 3 liters of fluid consisting initially of a saline solution. The dose of melphalan for the second perfusion will be increased.\n\nAn attempt to resect the residual lesion between 6-12 weeks after the second\n\ninterval perfusion may be made.", "detailedDescription"=>"Patients with extremity melanoma (Stage IIIA, IIIAB or Stage IV disease who have bulky symptomatic tumor located in the extremity) or patients with unresectable extremity sarcoma will undergo a double isolated limb perfusion with melphalan alone separated by approximately 4 to 6 weeks. The initial perfusion will be done with a melphalan dose of 6 mg/L limb volume and the interval perfusion with a dose of 9 mg/L limb volume. For patients with extremity sarcoma the tumor will be excised if feasible using a limb sparing resection between 6-12 weeks after the second perfusion. Technical feasibility of the double perfusion schedule will be determined. Overall response, duration of response, patterns of recurrence, and survival will be followed."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nHistologically confirmed unresectable sarcoma or intransit melanoma of the upper or lower extremity.\n\nExtremity sarcoma with no local resection option and would require amputation based upon abutment or proximity of the tumor to major neurovascular structures or bone or joint structures.\n\nMELANOMA PATIENTS:\n\nMust have history of two or more satellite intransit metastases of which one may be excised for diagnosis with the exception of patients with a single, large, deep, locally recurrent tumor or metastatic tumor (greater than 5 cm) that precludes an excision with primary closure. Stage IV melanoma must have a significant component (greater than 90%) of disease distal to the apex of the femoral triangle in the lower limb or distal to the insertion of the deltoid in the upper limb.\n\nMust have evaluable disease in the extremity. Melanoma must have dermal or subcutaneous lesion that can be measure directly in two diameters to assess tumor burden. Sarcoma must have either cutaneous lesions amenable to direct measurement or deeper lesions that can be measured on CT or MRI scans.\n\nPRIOR/CONCURRENT THERAPY:\n\nAt least 2 months since any regional therapy to the affected extremity.\n\nBIOLOGIC THERAPY: At least 1 month since Biologic Therapy.\n\nCHEMOTHERAPY: At least 1 month since chemotherapy.\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 0-2.\n\nLIFE EXPECTANCY: At least 6 months.\n\nHEMATOPOIETIC: Platelet count greater than 150,000/mm(3).\n\nHEPATIC: Bilirubin less than 2.0 mg/dL.\n\nRENAL: Creatinine less than 2.0 mg/dL.\n\nCARDIOVASCULAR: No history of congestive heart failure with an LVEF less than 40%.\n\nPULMONARY:\n\nNo chronic obstructive pulmonary disease.\n\nNo other chronic pulmonary disease with PFTs less than 50% predicted for age.\n\nOTHER:\n\nIF HIV POSITIVE: Must have CD4 cell count greater than 500/mL and, No clinical manifestations of AIDS. Coagulation parameters no greater than 1-2 seconds within the upper limit of normal.\n\nNo evidence of severe peripheral vascular disease.\n\nNo history of claudication or other ischemic vascular disease.\n\nNot pregnant or nursing."}, "identificationModule"=>{"nctId"=>"NCT00001577", "briefTitle"=>"Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity", "orgStudyIdInfo"=>{"id"=>"970131"}, "secondaryIdInfos"=>[{"id"=>"97-C-0131"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"double isolated limb perfusion with melphalan alone", "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"}}}}
