[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100063985":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":12,"responsibleParty":24,"collaborators":7,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":7,"eligibilityCriteria":32,"healthyVolunteers":28,"sex":33,"minAge":34,"maxAge":7,"enrollmentInfo":35,"targetDuration":7,"studyType":37,"phases":38,"briefSummary":40,"conditions":41,"keywords":43,"overallStatus":48,"whyStopped":49,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":59,"locationsCount":60},{"fullName":5,"class":6},"Agenus Inc.","INDUSTRY",null,[9],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"BIOLOGICAL","autologous human tumor-derived HSPPC-96",[13],{"facility":7,"status":7,"city":14,"state":15,"zip":7,"country":16,"countryCode":17,"cosmosGeoPoint":18,"geoPoint":23,"contacts":7},"Houston","Texas","United States","US",{"type":19,"coordinates":20},"Point",[21,22],-95.36327,29.76328,{"lat":22,"lon":21},{"type":25,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100063985","phase-2-trial-to-compare-the-routes-of-administration-of-an-investigational-personalized-therapeutic-cancer-vaccine-oncophage-hsppc-96-in-patients-with-metastatic-renal-cell-carcinoma-100063985",false,"NCT00082459","Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma","A Randomized Phase II Study Investigating the Route of Administration of Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma","Inclusion Criteria:\n\n* Suspected metastatic renal cell carcinoma (AJCC Stage IV) with intact primary tumor\n* No previous therapy for metastatic renal cell carcinoma\n* Measurable disease (RECIST criteria)\n* Primary tumor greater than or equal to 7cm on CT or MRI\n* ECOG performance status 0-1\n* At least 18 years old\n* Life expectancy \\> 3 months\n* Adequate cardiac function (NYHA I-II)\n* Not pregnant\n* Provide written informed consent\n* Absence of multiple liver metastases, brain or threatening bone metastases (axial skeleton and\u002For pathological features)\n* Planned complete nephrectomy\n\nExclusion Criteria:\n\n* History of primary or secondary immunodeficiency, or patients using systemic corticosteroids or cyclosporin A\n* Other cancer (including renal cell carcinoma) within the last five years (with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin)\n* Embolization of the renal artery prior to nephrectomy\n* Active, uncontrolled infection or other serious medical illnesses, preventing study completion, in the opinion of the Principal Investigator","ALL","18 Years",{"count":36,"type":7},40,"INTERVENTIONAL",[39],"PHASE2","The goal of this trial is to determine the safety of HSPPC-96 and which route of administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic agent made from an individual patient's tumor.",[42],"Renal Cell Carcinoma",[44,45,46,47],"Kidney Cancer","Renal","Tumor","Immunotherapy","TERMINATED","Lack of enrollment","2012-09-06",{"date":52,"type":53},"2012-09-07","ESTIMATED",{"date":55,"type":7},"2002-07",{"date":57,"type":58},"2005-12","ACTUAL",{"name":5,"class":6},1]