Nctid:
NCT00001587
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-28"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D009362", "term"=>"Neoplasm Metastasis"}, {"id"=>"D008113", "term"=>"Liver Neoplasms"}], "ancestors"=>[{"id"=>"D009385", "term"=>"Neoplastic Processes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D008107", "term"=>"Liver Diseases"}], "browseLeaves"=>[{"id"=>"M12307", "name"=>"Neoplasm Metastasis", "asFound"=>"Neoplasm Metastasis", "relevance"=>"HIGH"}, {"id"=>"M11113", "name"=>"Liver Neoplasms", "asFound"=>"Liver Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M2454", "name"=>"Hyperthermia", "relevance"=>"LOW"}, {"id"=>"M8464", "name"=>"Fever", "relevance"=>"LOW"}, {"id"=>"M12330", "name"=>"Neoplastic Processes", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M11107", "name"=>"Liver Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D008558", "term"=>"Melphalan"}], "ancestors"=>[{"id"=>"D018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000477", "term"=>"Alkylating Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D019653", "term"=>"Myeloablative Agonists"}, {"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M11541", "name"=>"Melphalan", "asFound"=>"Powder", "relevance"=>"HIGH"}, {"id"=>"M11110", "name"=>"Liver Extracts", "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"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>30}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1997-09"}, "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"=>["Hyperthermia", "Metastases", "Organ Perfusion", "Regional Therapy"], "conditions"=>["Liver Neoplasms", "Neoplasm Metastasis"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9467038", "type"=>"BACKGROUND", "citation"=>"Alexander HR Jr, Bartlett DL, Libutti SK. Isolated hepatic perfusion: a potentially effective treatment for patients with metastatic or primary cancers confined to the liver. Cancer J Sci Am. 1998 Jan-Feb;4(1):2-11. No abstract available."}, {"pmid"=>"9552055", "type"=>"BACKGROUND", "citation"=>"Alexander HR Jr, Bartlett DL, Libutti SK, Fraker DL, Moser T, Rosenberg SA. Isolated hepatic perfusion with tumor necrosis factor and melphalan for unresectable cancers confined to the liver. J Clin Oncol. 1998 Apr;16(4):1479-89. doi: 10.1200/JCO.1998.16.4.1479."}]}, "descriptionModule"=>{"briefSummary"=>"Patients with unresectable primary or metastatic cancer confined to the liver will undergo a 1 hour hyperthermic isolated hepatic perfusion (IHP) via the portal vein and hepatic artery with escalating dose melphalan. Patients eligible for this protocol are those with non-colorectal histologies and those with colorectal cancer previously treated with intra-arterial FUDR. Hepatic and systemic toxicity, response to treatment, duration of response, and survival will be followed.", "detailedDescription"=>"Patients with unresectable primary or metastatic cancer confined to the liver will undergo a 1 hour hyperthermic isolated hepatic perfusion (IHP) via the portal vein and hepatic artery with escalating dose melphalan. Patients eligible for this protocol are those with non-colorectal histologies and those with colorectal cancer previously treated with intra-arterial FUDR. Hepatic and systemic toxicity, response to treatment, duration of response, and survival will be followed."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Histologically or cytologically proven measurable primary or metastatic non-colorectal cancer limited to the parenchyma of the liver with no evidence of unresectable extrahepatic disease by preoperative radiological studies.\n\nLimited resectable extrahepatic disease is acceptable.\n\nPatients with colorectal cancer previously treated with intrahepatic arterial infusional therapy using FUDR, those with aberrant arterial anatomy such that infusional therapy is not possible, or those with limited extrahepatic disease such that regional therapy is not indicated will be eligible for this protocol.\n\nPatients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy in the month prior to the liver perfusion and must have recovered from all side effects.\n\nPatients must have an ECOG performance standard of 0, 1 or 2 on the day prior to treatment.\n\nPatients must have adequate hepatic function as evidence by bilirubin less than 2.0 and a PT and PTT that are within 1-2 seconds of the upper normal limit.\n\nNo patients with biopsy proven cirrhosis or evidence of significant portal hypertension by history, endoscopy, or radiologic studies will be included.\n\nNo patients with a history of congestive heart failure with an LVEF of equal to or less than 40% will be included.\n\nNo patients with COPD or other chronic pulmonary disease with PFT's less than 50% predicted for age will be included.\n\nPatients must be 18 years of age or older.\n\nPatients must have a platelet count greater than 100,000, a HCT greater than 27.0, a white blood count greater than 3000/ micrograms, and a creatinine less than or equal to 1.5 or a creatinine clearance of greater than 60 ml/min.\n\nNo pregnant patients or nursing mothers will be eligible.\n\nPatients must not be taking immunosuppressive drugs or on chronic anticoagulation.\n\nPatients must not have an active infection.\n\nPatients with severe allergic reactions to iodine contrast which can not be controlled by premedication with antihistamines and steroids are not eligible as a hepatic angiogram is needed for this procedure.\n\nPatients must not have HIV disease.\n\nPatients must be aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks.\n\nThe patient must be willing to sign an informed consent.\n\nPatients must not have a history of veno occlusive disease."}, "identificationModule"=>{"nctId"=>"NCT00001587", "briefTitle"=>"A Phase I Study of Isolated Hepatic Portal and Arterial Perfusion (IHP) With Escalating Dose Melphalan for Primary or Metastatic Unresectable Cancers of the Liver", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Phase I Study of Isolated Hepatic Portal and Arterial Perfusion (IHP) With Escalating Dose Melphalan for Primary or Metastatic Unresectable Cancers of the Liver", "orgStudyIdInfo"=>{"id"=>"970200"}, "secondaryIdInfos"=>[{"id"=>"97-C-0200"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Isolated hepatic portal and arterial perfusion", "type"=>"PROCEDURE"}, {"name"=>"Melphalan", "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"}}}}