Nctid:
NCT00001437
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-13"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D005355", "term"=>"Fibrosis"}, {"id"=>"D011832", "term"=>"Radiation Injuries"}], "ancestors"=>[{"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D014947", "term"=>"Wounds and Injuries"}], "browseLeaves"=>[{"id"=>"M8485", "name"=>"Fibrosis", "asFound"=>"Fibrosis", "relevance"=>"HIGH"}, {"id"=>"M2621", "name"=>"Radiation Fibrosis Syndrome", "relevance"=>"LOW"}, {"id"=>"M14679", "name"=>"Radiation Injuries", "asFound"=>"Radiation Injury", "relevance"=>"HIGH"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D010431", "term"=>"Pentoxifylline"}], "ancestors"=>[{"id"=>"D010726", "term"=>"Phosphodiesterase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D010975", "term"=>"Platelet Aggregation Inhibitors"}, {"id"=>"D011837", "term"=>"Radiation-Protective Agents"}, {"id"=>"D020011", "term"=>"Protective Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D014665", "term"=>"Vasodilator Agents"}, {"id"=>"D016166", "term"=>"Free Radical Scavengers"}, {"id"=>"D000975", "term"=>"Antioxidants"}], "browseLeaves"=>[{"id"=>"M13342", "name"=>"Pentoxifylline", "asFound"=>"Intra-articular", "relevance"=>"HIGH"}, {"id"=>"M13629", "name"=>"Phosphodiesterase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M13865", "name"=>"Platelet Aggregation Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"M14684", "name"=>"Radiation-Protective Agents", "relevance"=>"LOW"}, {"id"=>"M17412", "name"=>"Vasodilator Agents", "relevance"=>"LOW"}, {"id"=>"M4292", "name"=>"Antioxidants", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Vasodilator Agents", "abbrev"=>"VaDiAg"}, {"name"=>"Platelet Aggregation Inhibitors", "abbrev"=>"PlAggInh"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>50}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-06"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-05", "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"=>["Cytokines", "Fibrosis Intensity", "Post-Radiation Fibrosis", "Radiation Injury", "Trental"], "conditions"=>["Fibrosis", "Radiation Injuries"]}, "descriptionModule"=>{"briefSummary"=>"After initial assessment of their condition by specified clinical and laboratory parameters, each of the patients will be treated for 8 weeks at the standard pentoxifylline dose (400 mg po TID). Objective and subjective response parameters will be re-assessed at the end of the treatment and 8 weeks later for possible decay of response.", "detailedDescription"=>"Patients with late fibrovascular sequelae of radiation or of combined radiation and surgery, with quantifiable symptomatology or disability, will be eligible for this trial. This protocol is designed as an open label one arm study. (A placebo controlled randomized trial was approved by the IRB but after extensive negotiation, drug and placebo in slow release formulation will not be provided by the manufacturer). Up to fifty patients will be recruited. After initial assessment of their condition by specified clinical and laboratory parameters, each of the patients will be treated for 8 weeks at the standard pentoxifylline dose (400 mg po TID). Objective and subjective response parameters will be re-assessed at the end of the treatment and 8 weeks later for possible decay of response.\n\nIn addition to symptomatic objective and subjective response, blood and urine will be collected for TNF, TGF-beta, and FGF. Cutaneous blood flow and collagen subtyping will be performed on a subset of patients using Laser Doppler, functional MRI techniques and subcutaneous tissue biopsies. We will examine for correlation between clinical response and these biological responses."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"POPULATION CHARACTERISTICS:\n\nRegional advanced postradiation fibrosis of the neck, chest wall, pelvis, or extremities causing measurable impairment of specific function, i.e.: Decreased range of motion, Weakness, Sensory deficit, Pain requiring narcotics, Significantly altered activities of daily living.\n\nNone of these conditions present either before or during radiotherapy or attributed to surgery or chemotherapy.\n\nPatients with prostate cancer allowed if prostate-specific antigen (PSA) is less than 4.0 ng/mL and the last 3 PSA values were stable or decreasing. Abnormal bone scan or film acceptable if consistent with degenerative disease.\n\nNo recurrent or metastatic cancer.\n\nNo concurrent second cancer.\n\nPRIOR/CONCURRENT THERAPY: At least 3 months since pentoxifylline.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nPerformance status: Karnofsky 70%-100% (unrelated to postradiation fibrosis).\n\nCARDIOVASCULAR:\n\nNo symptomatic coronary artery disease with frequent anginal episodes necessitating any of the following during past 6 months: Coronary artery bypass, Angioplasty, Pacemaker placement, Thrombolytic treatment.\n\nNo chronic cardiac failure with persistent hemodynamic abnormality and ejection fraction less than 40%.\n\nNo coagulation, platelet, or vascular disorder that threatens to cause bleeding.\n\nOTHER:\n\nNo intolerance to pentoxifylline or other xanthines (e.g., caffeine, theophylline, theobromine).\n\nNo seizure disorder.\n\nNo peptic ulcer disease.\n\nWilling to undergo serial evaluations (excluding biopsies, laser Doppler, MRI) by NCI rehabilitation specialist for documentation and grading of functional disability.\n\nNo pregnant or nursing women.\n\nAdequate contraception encouraged in fertile women."}, "identificationModule"=>{"nctId"=>"NCT00001437", "briefTitle"=>"Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis", "orgStudyIdInfo"=>{"id"=>"950138"}, "secondaryIdInfos"=>[{"id"=>"95-C-0138"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"pentoxifylline", "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"}}}}
