Nctid:
NCT00001446
Payload:
{"FullStudy"=>{"Rank"=>497940, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000011471", "ConditionMeshTerm"=>"Prostatic Neoplasms"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000005834", "ConditionAncestorTerm"=>"Genital Neoplasms, Male"}, {"ConditionAncestorId"=>"D000014565", "ConditionAncestorTerm"=>"Urogenital Neoplasms"}, {"ConditionAncestorId"=>"D000009371", "ConditionAncestorTerm"=>"Neoplasms by Site"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000005832", "ConditionAncestorTerm"=>"Genital Diseases, Male"}, {"ConditionAncestorId"=>"D000091662", "ConditionAncestorTerm"=>"Genital Diseases"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}, {"ConditionAncestorId"=>"D000011469", "ConditionAncestorTerm"=>"Prostatic Diseases"}, {"ConditionAncestorId"=>"D000052801", "ConditionAncestorTerm"=>"Male Urogenital Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M14335", "ConditionBrowseLeafName"=>"Prostatic Neoplasms", "ConditionBrowseLeafAsFound"=>"Prostatic Neoplasms", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M8946", "ConditionBrowseLeafName"=>"Genital Neoplasms, Male", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17315", "ConditionBrowseLeafName"=>"Urogenital Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2876", "ConditionBrowseLeafName"=>"Genital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8944", "ConditionBrowseLeafName"=>"Genital Diseases, Male", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2875", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14333", "ConditionBrowseLeafName"=>"Prostatic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M27095", "ConditionBrowseLeafName"=>"Male Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000013792", "InterventionMeshTerm"=>"Thalidomide"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000007166", "InterventionAncestorTerm"=>"Immunosuppressive Agents"}, {"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000007917", "InterventionAncestorTerm"=>"Leprostatic Agents"}, {"InterventionAncestorId"=>"D000000900", "InterventionAncestorTerm"=>"Anti-Bacterial Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000020533", "InterventionAncestorTerm"=>"Angiogenesis Inhibitors"}, {"InterventionAncestorId"=>"D000043924", "InterventionAncestorTerm"=>"Angiogenesis Modulating Agents"}, {"InterventionAncestorId"=>"D000006133", "InterventionAncestorTerm"=>"Growth Substances"}, {"InterventionAncestorId"=>"D000006131", "InterventionAncestorTerm"=>"Growth Inhibitors"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M9789", "InterventionBrowseLeafName"=>"Hormones", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16559", "InterventionBrowseLeafName"=>"Thalidomide", "InterventionBrowseLeafAsFound"=>"Offered", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M10212", "InterventionBrowseLeafName"=>"Immunosuppressive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10201", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4222", "InterventionBrowseLeafName"=>"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4214", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M22318", "InterventionBrowseLeafName"=>"Angiogenesis Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9231", "InterventionBrowseLeafName"=>"Growth Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"64"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"September 1995"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"August 2000", "CompletionDateStruct"=>{"CompletionDate"=>"July 2001"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"December 9, 2002", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"December 10, 2002", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Angiogenesis", "Malignancy", "Neuropathy", "Pharmacokinetics", "Sedation"]}, "ConditionList"=>{"Condition"=>["Prostatic Neoplasm"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"5652850", "ReferenceType"=>"background", "ReferenceCitation"=>"Bakay B, Nyhan WL. Binding of thalidomide by macromolecules in the fetal and maternal rat. J Pharmacol Exp Ther. 1968 Jun;161(2):348-60. No abstract available."}, {"ReferencePMID"=>"7130490", "ReferenceType"=>"background", "ReferenceCitation"=>"Barnhill RL, McDougall AC. Thalidomide: use and possible mode of action in reactional lepromatous leprosy and in various other conditions. J Am Acad Dermatol. 1982 Sep;7(3):317-23. doi: 10.1016/s0190-9622(82)70118-5."}, {"ReferencePMID"=>"21106711", "ReferenceType"=>"derived", "ReferenceCitation"=>"Sissung TM, Danesi R, Kirkland CT, Baum CE, Ockers SB, Stein EV, Venzon D, Price DK, Figg WD. Estrogen receptor alpha and aromatase polymorphisms affect risk, prognosis, and therapeutic outcome in men with castration-resistant prostate cancer treated with docetaxel-based therapy. J Clin Endocrinol Metab. 2011 Feb;96(2):E368-72. doi: 10.1210/jc.2010-2070. Epub 2010 Nov 24."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide in patients with hormone-refractory prostate cancer.\n\nAn important aspect of this study is to characterize the pharmacokinetics of thalidomide, as well as make correlations between the degree of angiogenesis occurring in a patient and the activity of thalidomide.", "DetailedDescription"=>"This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide in patients with hormone-refractory prostate cancer. Patients will be randomized to two different treatment arms (low dose versus high dose). An important aspect of this study is to characterize the pharmacokinetics of thalidomide, as well as make correlations between the degree of angiogenesis occurring in a patient and the activity of thalidomide. Each patient that has biopsiable lesions will undergo a pretreatment biopsy of their prostate (or other site of soft tissue disease) and repeat after 2 to 6 months of treatment. Additional information will be obtained on the changes in the circulating levels of the following growth factors: bFGF, TNF, VEGF, and TGFB. Neurological complications are the primary dose-limiting toxicity anticipated with chronic thalidomide administration."}, "EligibilityModule"=>{"Gender"=>"Male", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nHistologically documented adenocarcinoma of the prostate. Confirmation by the Clinical Center Pathology Department required.\n\nCT-defined soft tissue disease required for staging if prostate-specific antigen (PSA) less than 20 ng/mL.\n\nProgressive hormone-refractory disease for 1 month prior to entry (and after withdrawal of any antiandrogens), documented by at least one of the following: 3 consecutive rising levels of PSA at least 1 week apart. 1 measurement at least 50% greater than PSA nadir after last therapy.\n\nNew bone metastasis on Tc-99 bone scintigraphy.\n\nProgression of measurable or evaluable soft-tissue metastases.\n\nDevelopment of new area of disease. 25% increase in previously measured lesions.\n\nTotal androgen ablation required. Testosterone in castrate range.\n\nConcurrent luteinizing hormone-releasing hormone (LHRH) agonist required if not surgically castrated.\n\nNo prior prostate irradiation or radical prostatectomy unless other biopsiable lesions available.\n\nUrgent local problems corrected prior to entry (e.g., severe bone pain, spinal cord compression, urinary flow obstruction).\n\nNo brain metastases.\n\nPRIOR/CONCURRENT THERAPY:\n\nThyroid replaced concurrent to start of study for patients with chemical hypothyroidism.\n\nThyroid replaced prior to study for patients with clinical hypothyroidism.\n\nBiologic Therapy: At least 4 weeks since Biologic Therapy and recovered from all toxic effects.\n\nChemotherapy:\n\nNo prior suramin.\n\nAt least 4 weeks since chemotherapy and recovered from all toxic effects.\n\nEndocrine Therapy:\n\nSee Disease Characteristics.\n\nAt least 4 weeks since hormonal therapy except LHRH agonist therapy.\n\nRadiotherapy:\n\nSee Disease Characteristics.\n\nAt least 4 weeks since radiotherapy (6 weeks since strontium).\n\nSurgery: See Disease Characteristics.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nPerformance status: ECOG 0-2.\n\nLife expectancy: More than 3 months.\n\nHematopoietic:\n\nAbsolute granulocyte count greater than 1,000/mm(3).\n\nPlatelet count greater than 75,000/mm(3).\n\nHemoglobin greater than 8.0 g/dL (transfusion allowed if requirement maintained for more than 30 days OR bleeding identified and treated).\n\nHepatic:\n\nBilirubin no greater than 1.5 times normal.\n\nAST and ALT less than 2.5 times normal.\n\nRenal:\n\nCreatinine no greater than 1.5 mg/dL OR\n\nCreatinine clearance greater than 40 mL/min.\n\nProteinuria no greater than 2+ OR less than 500 mg/24 hr (except patients with ureteral stents).\n\nBUN normal.\n\nElectrolytes normal.\n\nUrinalysis normal.\n\nCardiovascular:\n\nNo unstable or newly diagnosed angina.\n\nNo myocardial infarction within 6 months.\n\nNo NYHA class II-IV congestive heart failure.\n\nPulmonary:\n\nNo chronic obstructive lung disease requiring oxygen therapy.\n\nNeurologic:\n\nNo clinically detectable peripheral neuropathy greater than grade 1.\n\nNo seizures within 10 years.\n\nNo anticonvulsants.\n\nNo requirement for sedatives or hypnotics.\n\nOTHER:\n\nNormal thyroid function tests at least 4 weeks prior to study and throughout study.\n\nNo concurrent anticoagulants.\n\nNo active infection.\n\nOff antibiotics at least 1 week.\n\nUreteral stent or Foley catheter allowed with no antibiotics.\n\nHIV negative.\n\nNo concurrent life-threatening illness.\n\nNo concurrent malignancies.\n\nAbility to travel to the National Institutes of Health.\n\nAdequate contraception required of sexually active patients and their partners during and for 2 months after therapy."}, "IdentificationModule"=>{"NCTId"=>"NCT00001446", "BriefTitle"=>"A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer", "OrgStudyIdInfo"=>{"OrgStudyId"=>"950178"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"95-C-0178"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"thalidomide", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Cancer Institute (NCI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Cancer Institute (NCI)", "LeadSponsorClass"=>"NIH"}}}}}}