[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100074837":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":58,"centralContacts":28,"locations":63,"responsibleParty":76,"collaborators":78,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":28,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":28,"enrollmentInfo":91,"targetDuration":28,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":28,"overallStatus":108,"whyStopped":28,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":28,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of Washington","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A (cellular infusions after cyclophosphamide)","EXPERIMENTAL","Patients receive low-dose cyclophosphamide IV on day -1 and 3 escalating doses of autologous ex vivo-expanded HER2-specific T cells IV over 30 minutes on days 1, 10, and 20.",[13,14,15,16],"Drug: ex vivo-expanded HER2-specific T cells","Drug: cyclophosphamide","Other: flow cytometry","Other: immunoenzyme technique",{"label":18,"type":10,"description":19,"interventionNames":20},"Group B (cellular infusions after ONTAK conditioning)","Patients receive denileukin diftitox IV over 1 hour on day -1 and 3 escalating doses of autologous ex vivo-expanded HER2-specific T cells IV over 30 minutes on days 1, 10, and 20.",[13,21,15,16],"Biological: denileukin diftitox",[23,29,39,48,52],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","ex vivo-expanded HER2-specific T cells","Laboratory-expanded T cells, given IV",[9,18],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"cyclophosphamide","Given IV",[9],[34,35,36,37,38],"CPM","CTX","Cytoxan","Endoxan","Endoxana",{"type":40,"name":41,"description":31,"armGroupLabels":42,"otherNames":43},"BIOLOGICAL","denileukin diftitox",[18],[44,45,46,47],"DAB389 interleukin-2","DAB389 interleukin-2 immunotoxin","DAB389-IL2","DABIL2",{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":28},"flow cytometry","Intracellular cytokine staining (correlative study)",[9,18],{"type":6,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"immunoenzyme technique","ELIspot assay (correlative study)",[9,18],[57],"immunoenzyme techniques",[59],{"name":60,"affiliation":61,"role":62},"Mary Disis","Fred Hutchinson Cancer Research Center\u002FUniversity of Washington Cancer Consortium","PRINCIPAL_INVESTIGATOR",[64],{"facility":61,"status":28,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":28},"Seattle","Washington","98109","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-122.33207,47.60621,{"lat":74,"lon":73},{"type":77,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[79],{"name":80,"class":81},"National Cancer Institute (NCI)","NIH","100074837","phase-1-cyclophosphamide-or-denileukin-diftitox-followed-by-expanding-a-patients-own-t-cells-in-the-laboratory-in-treating-patients-with-her-2neu-overexpressing-metastatic-breast-cancer-ovarian-cancer-or-non-small-cell-lung-cancer-previously-treated-with-her-2neu-vaccine-100074837",false,"NCT00228358","Cyclophosphamide or Denileukin Diftitox Followed By Expanding a Patient's Own T Cells in the Laboratory in Treating Patients With HER-2\u002FNeu Overexpressing Metastatic Breast Cancer, Ovarian Cancer, or Non-Small Cell Lung Cancer Previously Treated With HER-2\u002FNeu Vaccine","A Phase I Study of Infusion of HER-2\u002FNeu Specific T Cells in Patients With Advanced Stage HER-2\u002FNeu Expressing Cancers Who Have Received a HER-2\u002FNeu Vaccine","Inclusion Criteria:\n\n* Patients with progressive HER2\u002Fneu overexpressing metastatic breast, ovarian, or non-small cell lung cancer not considered curable by conventional therapies, including trastuzumab\n\n  * Extra-skeletal disease that can be accurately measured \\>= 10 mm by standard imaging techniques that can include but not limited to computed tomography (CT), positron emission tomography (PET), magnetic resonance imaging (MRI)\n  * Skeletal or bone-only disease which is measurable by Fludeoxyglucose F 18 (FDG) PET imaging will also be allowed\n  * Patients with ovarian cancer may have measurable disease; however, their only indication of progression may be an abnormal CA-125\n* Patients must have documented HER-2\u002Fneu overexpression in their tumor (either primary or metastasis) as was required per the eligibility criteria of their original vaccination protocol\n* Patients must have received HER2-specific vaccinations while enrolled on a HER2 vaccine protocol approved at the University of Washington Human Subjects Division\n* Patients must have undergone leukapheresis after vaccination through a protocol approved at the University of Washington Human Subjects Division and have product stored for clinical use\n* Subjects must have a Performance Status Score (Zubrod\u002FEastern Cooperative Oncology Group \\[ECOG\\] Scale) = 0 or 1\n* Patients can be currently receiving trastuzumab and\u002For lapatinib and\u002For hormonal therapy and\u002For bisphosphonate therapy\n\n  * Patients on trastuzumab and\u002For lapatinib must have adequate cardiac function as demonstrated by multi gated acquisition (MUGA) scan or echocardiogram (ECHO) within 90 days of eligibility determination\n* Patients must be off all immunosuppressive treatments, and\u002For systemic steroid therapy, for at least 14 days prior to initiation of study treatment\n* Patients must be off chemotherapy and trastuzumab for at least 1 week prior to the first infusion of T cells\n* Men and women of reproductive ability must agree to contraceptive use during the study and for one month after the final T cell infusion\n* Patients with a history of brain metastases must have a stable head imaging study within 30 days of enrollment\n* White blood cells (WBC) \\>= 3000\u002Fmm\\^3\n* Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3\n* Hemoglobin (Hgb) \\>= 10 mg\u002Fdl\n* Platelets \\>= 75,000mm\\^3\n* Serum creatinine =\\\u003C 2.0 mg\u002Fdl or creatinine clearance \\> 60 ml\u002Fmin\n* Total bilirubin =\\\u003C 2.5 mg\u002Fdl\n* Aspartate aminotransferase (AST)\u002Fserum glutamic oxaloacetic transaminase (SGOT) =\\\u003C 3 times ULN\n\nExclusion Criteria:\n\n* Concurrent enrollment in other treatment studies\n* Patients with any of the following cardiac conditions:\n\n  * Symptomatic restrictive cardiomyopathy\n  * Unstable angina within the last 4 months prior to enrollment\n  * New York Heart Association functional class III-IV heart failure on active treatment\n* Patients with any clinically significant autoimmune disease uncontrolled with treatment\n* Pregnant or breast-feeding women\n* Known history of hypersensitivity to diphtheria toxin or interleukin (IL)-2 (only for subjects enrolled in Group B)","ALL","18 Years",{"count":92,"type":93},8,"ACTUAL","INTERVENTIONAL",[96],"PHASE1","This phase I trial studies the safety and the ability to expand laboratory-treated T cells when given together with cyclophosphamide or denileukin diftitox in treating patients with human epidermal growth factor receptor (HER)-2\u002Fneu overexpressing metastatic breast cancer, ovarian cancer, or non-small cell lung cancer previously treated with HER-2\u002Fneu vaccine. Laboratory-expanded T cells may help the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapy, such as denileukin diftitox, may stimulate the immune system in different ways and stop tumor cells from growing. Giving laboratory-treated T cells together with cyclophosphamide or denileukin diftitox may allow the immune system to kill more tumor cells",[99,100,101,102,103,104,105,106,107],"HER2-positive Breast Cancer","Recurrent Breast Cancer","Recurrent Non-small Cell Lung Cancer","Recurrent Ovarian Epithelial Cancer","Recurrent Ovarian Germ Cell Tumor","Stage IV Breast Cancer","Stage IV Non-small Cell Lung Cancer","Stage IV Ovarian Epithelial Cancer","Stage IV Ovarian Germ Cell Tumor","COMPLETED","2014-11-07",{"date":111,"type":112},"2014-11-11","ESTIMATED",{"date":114,"type":28},"2003-06",{"name":5,"class":6},1]