[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100074505":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":19,"locations":24,"responsibleParty":68,"collaborators":19,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":19,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":19,"enrollmentInfo":79,"targetDuration":19,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":92,"whyStopped":19,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Vical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"A","EXPERIMENTAL","IL-2-encoding plasmid formulated in phosphate-buffered saline at 0.5 mg\u002FmL, 1.5 mg\u002FmL, and 5.0 mg\u002FmL (VCL-IM01) intratumorally injected and followed by electroporation with Inovio MedPulser® 1.0 cm array with needles up to 3 cm long (one 6-pulse cycle per tumor).",[13],"Genetic: VCL-IM01 (encoding IL-2) with Electroporation",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"GENETIC","VCL-IM01 (encoding IL-2) with Electroporation",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Dmitri D. Kharkevitch, MD, PhD","STUDY_DIRECTOR",[25,38,48,58],{"facility":26,"status":19,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":19},"Location #2","Mobile","Alabama","36606","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-88.04305,30.69436,{"lat":36,"lon":35},{"facility":39,"status":19,"city":40,"state":41,"zip":42,"country":30,"countryCode":31,"cosmosGeoPoint":43,"geoPoint":47,"contacts":19},"Location #3","Denver","Colorado","80045",{"type":33,"coordinates":44},[45,46],-104.9847,39.73915,{"lat":46,"lon":45},{"facility":49,"status":19,"city":50,"state":51,"zip":52,"country":30,"countryCode":31,"cosmosGeoPoint":53,"geoPoint":57,"contacts":19},"Location #1","Chicago","Illinois","60068",{"type":33,"coordinates":54},[55,56],-87.65005,41.85003,{"lat":56,"lon":55},{"facility":59,"status":19,"city":60,"state":61,"zip":62,"country":30,"countryCode":31,"cosmosGeoPoint":63,"geoPoint":67,"contacts":19},"Location #4","Montclair","New Jersey","07042",{"type":33,"coordinates":64},[65,66],-74.20903,40.82593,{"lat":66,"lon":65},{"type":69,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100074505","phase-1-a-trial-to-evaluate-the-safety-of-intratumoral-vcl-im01-followed-by-electroporation-in-metastatic-melanoma-100074505",false,"NCT00223899","A Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma","A Phase 1, Multi-Center, Open-Label, Dose-Escalation Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma","Inclusion Criteria - Key criteria include:\n\n* Confirmed recurrent metastatic melanoma\n* Tumor(s) to be treated must be at least 1 cm by 1 cm, and be accessible to treatment\n* Able to carry out normal daily activities and light work without assistance\n* Not currently receiving chemotherapy or immunotherapy\n* Normal blood chemistries and blood cell counts (elevation of LDH to less than or equal to 1.5 times normal is allowed)\n* Able and willing to give informed consent.\n\nExclusion Criteria - Key criteria include:\n\n* History of brain tumors (resected or stereotactically treated is allowed)\n* History of liver tumors\n* Subjects whose melanoma can be cured by surgery\n* Pregnant\n* Subjects with electronic pacemakers, defibrillators, or any other implanted electronic device.","ALL","18 Years",{"count":80,"type":81},26,"ACTUAL","INTERVENTIONAL",[84],"PHASE1","To evaluate the safety of intratumorally injected VCL-IM01 at doses of 0.5 mg (1 tumor), 1.5 mg (1 tumor), 5 mg (1 tumor), 10 mg (2 tumors, 5 mg per tumor) and 15 mg (3 tumors, 5 mg per tumor) followed by electroporation.",[87],"Metastatic Melanoma",[89,90,91],"Melanoma","Electroporation","IL-2","COMPLETED","2019-02-25",{"date":95,"type":81},"2019-02-27",{"date":97,"type":19},"2005-07",{"date":99,"type":81},"2008-10",{"name":5,"class":6},4]