Nctid:
NCT00002846
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007680", "term"=>"Kidney Neoplasms"}, {"id"=>"D002292", "term"=>"Carcinoma, Renal Cell"}], "ancestors"=>[{"id"=>"D014571", "term"=>"Urologic Neoplasms"}, {"id"=>"D014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D007674", "term"=>"Kidney Diseases"}, {"id"=>"D014570", "term"=>"Urologic Diseases"}, {"id"=>"D052801", "term"=>"Male Urogenital Diseases"}, {"id"=>"D000230", "term"=>"Adenocarcinoma"}, {"id"=>"D002277", "term"=>"Carcinoma"}, {"id"=>"D009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}], "browseLeaves"=>[{"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M10703", "name"=>"Kidney Neoplasms", "asFound"=>"Kidney Cancer", "relevance"=>"HIGH"}, {"id"=>"M5548", "name"=>"Carcinoma, Renal Cell", "asFound"=>"Kidney Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M17320", "name"=>"Urologic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M10698", "name"=>"Kidney Diseases", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"T4906", "name"=>"Renal Cell Carcinoma", "asFound"=>"Kidney Cancer", "relevance"=>"HIGH"}, {"id"=>"T1341", "name"=>"Clear Cell Renal Cell Carcinoma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C082598", "term"=>"Aldesleukin"}], "ancestors"=>[{"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M10411", "name"=>"Interleukin-2", "relevance"=>"LOW"}, {"id"=>"M225496", "name"=>"Aldesleukin", "asFound"=>"Tacrolimus", "relevance"=>"HIGH"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>14}}, "statusModule"=>{"overallStatus"=>"UNKNOWN", "lastKnownStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"1995-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2003-12", "lastUpdateSubmitDate"=>"2013-12-18", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2003-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2013-12-19", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2003-01-27", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["stage IV renal cell cancer", "recurrent renal cell cancer"], "conditions"=>["Kidney Cancer"]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.\n\nPURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer.", "detailedDescription"=>"OBJECTIVES:\n\n* Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2.\n* Assess the toxicity associated with this treatment.\n\nOUTLINE: Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3. Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course. Responding patients may continue therapy every 2 months provided toxicity is limited.\n\nPatients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy.\n\nPatients are followed for survival.\n\nPROJECTED ACCRUAL: A total of 14 patients will be accrued for this study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\n* Histologically confirmed renal cell carcinoma (RCC) that is metastatic or recurrent\n\n * No central nervous system or major nerve involvement\n * No more than 25% estimated hepatic replacement by tumor on CT or MRI\n* Measurable disease required\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 80%-100%\n\nLife expectancy:\n\n* Greater than 3 months\n\nHematopoietic:\n\n* Platelet count at least 80,000/mm3\n\nHepatic:\n\n* Bilirubin normal\n* AST and ALT no greater than 3 times normal\n\nRenal:\n\n* Creatinine normal\n\nCardiovascular:\n\n* Stress cardiac exam normal (exam performed in patients aged 50 and older and in those with potential cardiac disease suggested by history, physical exam, or EKG)\n\nPulmonary:\n\n* FEV1 and VC greater than 65% of predicted (tests performed in patients with significant smoking history and in those with potential pulmonary disease suggested by history, physical exam, or x-ray)\n\nOther:\n\n* No sites of ongoing bleeding\n* No HIV antibody or AIDS\n* No hepatitis B antigen\n* No systemic infection\n* No requirement for steroids\n* No psychiatric disease that precludes informed consent or safe administration of immunotherapy\n* No second malignancy except:\n\n * Basal cell carcinoma\n * In situ cervical cancer\n * Other cancer provided all evaluable lesions are documented RCC\n* No pregnant or nursing women\n* Effective contraception required of fertile women\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior interleukin-2 therapy\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* At least 28 days since therapy for RCC"}, "identificationModule"=>{"nctId"=>"NCT00002846", "briefTitle"=>"Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer", "organization"=>{"class"=>"NIH", "fullName"=>"National Cancer Institute (NCI)"}, "officialTitle"=>"TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2", "orgStudyIdInfo"=>{"id"=>"CDR0000065085"}, "secondaryIdInfos"=>[{"id"=>"CMC-09-95-15B"}, {"id"=>"NCI-V96-1038"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"aldesleukin", "type"=>"BIOLOGICAL"}, {"name"=>"conventional surgery", "type"=>"PROCEDURE"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"28232-2861", "city"=>"Charlotte", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Carolinas Medical Center", "geoPoint"=>{"lat"=>35.22709, "lon"=>-80.84313}}], "overallOfficials"=>[{"name"=>"Richard L. White, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Blumenthal Cancer Center at Carolinas Medical Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Blumenthal Cancer Center at Carolinas Medical Center", "class"=>"OTHER"}}}}