Nctid:
NCT00002687
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009181", "term"=>"Mycoses"}, {"id"=>"D008223", "term"=>"Lymphoma"}, {"id"=>"D009182", "term"=>"Mycosis Fungoides"}], "ancestors"=>[{"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D016410", "term"=>"Lymphoma, T-Cell, Cutaneous"}, {"id"=>"D016399", "term"=>"Lymphoma, T-Cell"}, {"id"=>"D008228", "term"=>"Lymphoma, Non-Hodgkin"}], "browseLeaves"=>[{"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M11220", "name"=>"Lymphoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M18829", "name"=>"Lymphoma, T-Cell", "relevance"=>"LOW"}, {"id"=>"M18832", "name"=>"Lymphoma, T-Cell, Cutaneous", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "asFound"=>"Mycosis", "relevance"=>"HIGH"}, {"id"=>"M12137", "name"=>"Mycosis Fungoides", "asFound"=>"Mycosis Fungoides", "relevance"=>"HIGH"}, {"id"=>"M15560", "name"=>"Sezary Syndrome", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M11225", "name"=>"Lymphoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M11203", "name"=>"Lymphatic Diseases", "relevance"=>"LOW"}, {"id"=>"M10206", "name"=>"Immunoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}, {"id"=>"M11222", "name"=>"Lymphoma, Non-Hodgkin", "relevance"=>"LOW"}, {"id"=>"T3543", "name"=>"Lymphosarcoma", "relevance"=>"LOW"}, {"id"=>"T1689", "name"=>"Cutaneous T-cell Lymphoma", "relevance"=>"LOW"}, {"id"=>"T3986", "name"=>"Mycosis Fungoides", "asFound"=>"Mycosis Fungoides", "relevance"=>"HIGH"}, {"id"=>"T5200", "name"=>"Sezary Syndrome", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"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"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-02"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2012-11", "completionDateStruct"=>{"date"=>"2003-07", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2012-11-30", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2003-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2012-12-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2003-01-27", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2003-07", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["stage II cutaneous T-cell non-Hodgkin lymphoma", "stage III cutaneous T-cell non-Hodgkin lymphoma", "stage IV cutaneous T-cell non-Hodgkin lymphoma", "recurrent cutaneous T-cell non-Hodgkin lymphoma", "stage II mycosis fungoides/Sezary syndrome", "stage III mycosis fungoides/Sezary syndrome", "stage IV mycosis fungoides/Sezary syndrome", "recurrent mycosis fungoides/Sezary syndrome"], "conditions"=>["Lymphoma"]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.\n\nPURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides.", "detailedDescription"=>"OBJECTIVES:\n\n* Determine the maximum tolerated dose and toxicity of interleukin-2 in patients with stage IIB-IV mycosis fungoides.\n* Determine the response rate of patients treated with this regimen.\n* Determine the immunologic response to this regimen in peripheral blood leukocytes and serum of these patients.\n\nOUTLINE: This is a dose escalation study.\n\nPatients receive interleukin-2 (IL-2) subcutaneously on days 1-5 during weeks 1-3 and on days 1-3 and 5 during week 4. Treatment repeats every 4 weeks for 4 courses.\n\nCohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity. Six additional patients receive IL-2 at 1 dose level preceding the MTD.\n\nPatients are followed at least 3 times during year 1 and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 16-30 patients will be accrued for this study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\n* Clinically and histologically proven diagnosis of 1 of the following:\n\n * Mycosis fungoides (MF) meeting 1 of the following conditions:\n\n * Stage IIB disease that has failed psoralen ultraviolet A (PUVA) light therapy and topical chemotherapy (mechlorethamine and/or carmustine)\n * Stage III disease with generalized erythroderma\n * Stage IV disease with biopsy proven nodal or visceral involvement\n * Sezary syndrome\n\n * Stage III MF with a minimum of 20% Sezary cells (based on total WBC)\n* No clinically significant ascites or pleural effusion\n\n * Clinically significant pleural effusion defined as shortness of breath with oxygen saturation less than 90%\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 80\n\nPerformance status:\n\n* Karnofsky 70-100%\n\nLife expectancy:\n\n* At least 16 weeks\n\nHematopoietic:\n\n* See Disease Characteristics\n* WBC at least 3,500/mm\\^3\n* Granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 11.5 g/dL\n\nHepatic:\n\n* Bilirubin less than 2.5 times normal\n* SGOT less than 2.5 times normal\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL\n* No nephrotic syndrome\n\nCardiovascular:\n\n* No history of myocardial infarction or congestive heart failure\n* No symptomatic coronary artery disease\n* No clinically manifest hypotension\n* No severe hypertension\n* No arrhythmia on electrocardiogram\n* No edema\n* No contraindication to pressor agents\n\nPulmonary:\n\n* See Disease Characteristics\n* No dyspnea at rest or severe exertional dyspnea\n\nNeurologic:\n\n* No significant CNS dysfunction, including any of the following:\n\n * Seizure disorder\n * Active cerebrovascular disease\n * Dementia or delirium\n\nOther:\n\n* No autoimmune disease, including psoriasis\n* No uncontrolled peptic ulcer disease\n* No uncontrolled infection\n* No history of adverse reaction to interleukin-2\n* HIV and HTLV-I negative\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior systemic or topical chemotherapy (6 weeks since prior mitomycin or nitrosoureas)\n\nEndocrine therapy:\n\n* At least 1 week since prior corticosteroids\n* No concurrent corticosteroids\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy\n\nSurgery:\n\n* No prior organ allograft\n* At least 3 weeks since other prior major surgery\n\nOther:\n\n* At least 4 weeks since prior immunosuppressive therapy\n* At least 2 weeks since prior phototherapy (ultraviolet B \\[UVB\\] or PUVA light therapy)\n* No concurrent phototherapy (UVB or PUVA light therapy)"}, "identificationModule"=>{"nctId"=>"NCT00002687", "briefTitle"=>"Interleukin-2 in Treating Patients With Mycosis Fungoides", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Washington"}, "officialTitle"=>"Phase 1 Trial of Subcutaneous [SC]; Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides [Stage IIb, III, IV]", "orgStudyIdInfo"=>{"id"=>"CDR0000064412"}, "secondaryIdInfos"=>[{"id"=>"UW-24218-A/E"}, {"id"=>"NCI-V95-0758"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"aldesleukin", "type"=>"BIOLOGICAL"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"98195-6043", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"University of Washington Medical Center", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}], "overallOfficials"=>[{"name"=>"John A. Thompson, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Seattle Cancer Care Alliance"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Washington", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}