Nctid:
NCT00001381
Payload:
{"FullStudy"=>{"Rank"=>497994, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000002277", "ConditionMeshTerm"=>"Carcinoma"}, {"ConditionMeshId"=>"D000002295", "ConditionMeshTerm"=>"Carcinoma, Transitional Cell"}, {"ConditionMeshId"=>"D000001749", "ConditionMeshTerm"=>"Urinary Bladder Neoplasms"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000009375", "ConditionAncestorTerm"=>"Neoplasms, Glandular and Epithelial"}, {"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000014571", "ConditionAncestorTerm"=>"Urologic Neoplasms"}, {"ConditionAncestorId"=>"D000014565", "ConditionAncestorTerm"=>"Urogenital Neoplasms"}, {"ConditionAncestorId"=>"D000009371", "ConditionAncestorTerm"=>"Neoplasms by Site"}, {"ConditionAncestorId"=>"D000052776", "ConditionAncestorTerm"=>"Female Urogenital Diseases"}, {"ConditionAncestorId"=>"D000005261", "ConditionAncestorTerm"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}, {"ConditionAncestorId"=>"D000001745", "ConditionAncestorTerm"=>"Urinary Bladder Diseases"}, {"ConditionAncestorId"=>"D000014570", "ConditionAncestorTerm"=>"Urologic Diseases"}, {"ConditionAncestorId"=>"D000052801", "ConditionAncestorTerm"=>"Male Urogenital Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M5030", "ConditionBrowseLeafName"=>"Urinary Bladder Neoplasms", "ConditionBrowseLeafAsFound"=>"Carcinoma of the Bladder", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M5534", "ConditionBrowseLeafName"=>"Carcinoma", "ConditionBrowseLeafAsFound"=>"Carcinoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M5551", "ConditionBrowseLeafName"=>"Carcinoma, Transitional Cell", "ConditionBrowseLeafAsFound"=>"Carcinoma, Transitional Cell", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12320", "ConditionBrowseLeafName"=>"Neoplasms, Glandular and Epithelial", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12315", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17320", "ConditionBrowseLeafName"=>"Urologic Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17315", "ConditionBrowseLeafName"=>"Urogenital Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2875", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M27093", "ConditionBrowseLeafName"=>"Female Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14127", "ConditionBrowseLeafName"=>"Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8399", "ConditionBrowseLeafName"=>"Female Urogenital Diseases and Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5026", "ConditionBrowseLeafName"=>"Urinary Bladder Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17319", "ConditionBrowseLeafName"=>"Urologic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M27095", "ConditionBrowseLeafName"=>"Male Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T5693", "ConditionBrowseLeafName"=>"Transitional Cell Carcinoma", "ConditionBrowseLeafAsFound"=>"Transitional Cell Carcinoma", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000013498", "InterventionMeshTerm"=>"Suramin"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000969", "InterventionAncestorTerm"=>"Antinematodal Agents"}, {"InterventionAncestorId"=>"D000000871", "InterventionAncestorTerm"=>"Anthelmintics"}, {"InterventionAncestorId"=>"D000000977", "InterventionAncestorTerm"=>"Antiparasitic Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000014344", "InterventionAncestorTerm"=>"Trypanocidal Agents"}, {"InterventionAncestorId"=>"D000000981", "InterventionAncestorTerm"=>"Antiprotozoal Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M16279", "InterventionBrowseLeafName"=>"Suramin", "InterventionBrowseLeafAsFound"=>"Ref", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M4196", "InterventionBrowseLeafName"=>"Anthelmintics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4294", "InterventionBrowseLeafName"=>"Antiparasitic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4214", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4298", "InterventionBrowseLeafName"=>"Antiprotozoal Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"18"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"March 1994"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"January 2000", "CompletionDateStruct"=>{"CompletionDate"=>"December 2000"}, "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"=>["Adult", "Intravesical Chemotherapy"]}, "ConditionList"=>{"Condition"=>["Bladder Neoplasms", "Carcinoma, Transitional Cell"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"1512858", "ReferenceType"=>"background", "ReferenceCitation"=>"Gansler T, Vaghmar N, Olson JJ, Graham SD. Suramin inhibits growth factor binding and proliferation by urothelial carcinoma cell cultures. J Urol. 1992 Sep;148(3):910-4. doi: 10.1016/s0022-5347(17)36776-9."}, {"ReferencePMID"=>"8738403", "ReferenceType"=>"background", "ReferenceCitation"=>"Walther MM, Figg WD, Linehan WM. Intravesical suramin: a novel agent for the treatment of superficial transitional-cell carcinoma of the bladder. World J Urol. 1996;14 Suppl 1:S8-11. doi: 10.1007/BF00182057."}, {"ReferencePMID"=>"7933214", "ReferenceType"=>"background", "ReferenceCitation"=>"Walther MM, Trahan EE, Cooper M, Venzon D, Linehan WM. Suramin inhibits proliferation and DNA synthesis in transitional carcinoma cell lines. J Urol. 1994 Nov;152(5 Pt 1):1599-602. doi: 10.1016/s0022-5347(17)32486-2."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Patients with superficial transitional cell carcinoma of the bladder will be treated with intravesical suramin in a phase I dose escalating study. The toxicity of suramin administered in this fashion will be evaluated.", "DetailedDescription"=>"Patients with superficial transitional cell carcinoma of the bladder will be treated with intravesical suramin in a phase I dose escalating study. The toxicity of suramin administered in this fashion will be evaluated."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nHistologically confirmed superficial transitional cell carcinoma of the bladder pathologically staged as Tis, Ta, or T1. Visible tumors at time of treatment not required. No metastatic disease or muscle invasion.\n\nClinically useful pretreatment bladder function required.\n\nNo significant prostatic obstructive symptoms associated with impaired or incomplete bladder emptying.\n\nNo active urinary tract infection.\n\nPRIOR/CONCURRENT THERAPY:\n\nAt least 1 course of prior standard intravesical therapy required.\n\nAt least 4 weeks since intravesical treatment, with resolution of any local or systemic toxicity.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nPerformance status: ECOG 0 or 1.\n\nHematopoietic:\n\nWBC at least 3,300;\n\nHemoglobin at least 10 g/dL.\n\nHepatic:\n\nBilirubin no greater than 1.5 mg/dL;\n\nAST and ALT no greater than 2 times normal.\n\nRenal: Creatinine no greater than 1.5 mg/dL.\n\nOTHER:\n\nMedically able to undergo cystoscopy.\n\nNo pregnant women."}, "IdentificationModule"=>{"NCTId"=>"NCT00001381", "BriefTitle"=>"A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder", "OrgStudyIdInfo"=>{"OrgStudyId"=>"940098"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"94-C-0098"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"suramin", "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"}}}}}}
