[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100210207":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":11,"studyPopulation":11,"armGroups":22,"interventions":29,"overallOfficials":35,"centralContacts":43,"locations":49,"responsibleParty":124,"collaborators":11,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":11,"eligibilityCriteria":131,"healthyVolunteers":128,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":11,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":148,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"South Plains Oncology Consortium","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"To determine the Maximum Tolerated Dose (MTD) of MM-398 in combination with intravenous cyclophosphamide by assessing the occurrence of dose limiting toxicities",null,"12 months",[14],{"measure":15,"description":11,"timeFrame":12},"Measurement of plasma levels of study drug to determine the pharmacokinetic properties of MM-398 in combination with cyclophosphamide",{"allocation":17,"interventionModel":18,"interventionModelDescription":11,"primaryPurpose":19,"observationalModel":11,"timePerspective":11,"maskingInfo":20},"NA","SINGLE_GROUP","TREATMENT",{"masking":21,"maskingDescription":11,"whoMasked":11},"NONE",[23],{"label":24,"type":25,"description":26,"interventionNames":27},"MM-398 + cyclophosphamide","EXPERIMENTAL","MM-398+cyclophosphamide",[28],"Drug: MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"DRUG","MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide","chemotherapy",[24],[36,40],{"name":37,"affiliation":38,"role":39},"Paul Harker-Murray, MD","Midwest Children's Hospital","STUDY_CHAIR",{"name":41,"affiliation":42,"role":39},"Erin K Barr, MD","Texas Tech University Health Sciences Center",[44],{"name":45,"role":46,"phone":47,"phoneExt":11,"email":48},"Amanda Knight, RN, BSN","CONTACT","806-743-2690","amanda.knight@ttuhsc.edu",[50,70,83,96,110],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Cincinnati Children's Hospital Medical Center","RECRUITING","Cincinnati","Ohio","45229","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-84.51439,39.12711,{"lat":62,"lon":61},[65,67],{"name":11,"role":46,"phone":66,"phoneExt":11,"email":11},"513-636-4200",{"name":68,"role":69,"phone":11,"phoneExt":11,"email":11},"Joseph Pressey, MD","PRINCIPAL_INVESTIGATOR",{"facility":71,"status":52,"city":72,"state":73,"zip":74,"country":56,"countryCode":57,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"University Of Oklahoma Health Sciences Center","Oklahoma City","Oklahoma","73104",{"type":59,"coordinates":76},[77,78],-97.51643,35.46756,{"lat":78,"lon":77},[81],{"name":82,"role":46,"phone":11,"phoneExt":11,"email":11},"Haley Jones",{"facility":84,"status":52,"city":85,"state":86,"zip":87,"country":56,"countryCode":57,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"UT Southwestern","Dallas","Texas","75235",{"type":59,"coordinates":89},[90,91],-96.80667,32.78306,{"lat":91,"lon":90},[94],{"name":95,"role":46,"phone":11,"phoneExt":11,"email":11},"Alison Patterson",{"facility":42,"status":52,"city":97,"state":86,"zip":98,"country":56,"countryCode":57,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Lubbock","79430",{"type":59,"coordinates":100},[101,102],-101.85517,33.57786,{"lat":102,"lon":101},[105,109],{"name":106,"role":46,"phone":107,"phoneExt":11,"email":108},"Liza Villarreal","806-775-8590","liza.villarreal@ttuhsc.edu",{"name":41,"role":69,"phone":11,"phoneExt":11,"email":11},{"facility":38,"status":52,"city":111,"state":112,"zip":113,"country":56,"countryCode":57,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Milwaukee","Wisconsin","53226",{"type":59,"coordinates":115},[116,117],-87.90647,43.0389,{"lat":117,"lon":116},[120],{"name":121,"role":46,"phone":122,"phoneExt":11,"email":123},"Sophia Root","414-955-5025","sroot@mcw.edu",{"type":125,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100210207","phase-1-phase-1-dose-escalating-study-of-mm-398-irinotecan-sucrosofate-liposome-injection-plus-intravenous-cyclophosphamide-in-recurrent-or-refractory-pediatric-solid-tumors-100210207",false,"NCT02013336","Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically-confirmed Ewing sarcoma, rhabdomyosarcoma, neuroblastoma, or osteosarcoma\n* Disease progression after prior therapy in locally advanced or metastatic setting\n* Measurable or evaluable disease based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria\n* Age 12 months to \\\u003C21 years\n* Adequate bone marrow reserves, hepatic function, and renal function\n* Recovered from effects of any prior surgery or cancer therapy\n* Patients 18 years or older will provide written consent. A parent or legal guardian of a patient \\\u003C18 years of age will provide informed consent and patients 11 to 18 years of age will provide written assent or as per participating institutional policy.\n\nExclusion Criteria:\n\n* Clinically significant gastrointestinal disorders\n* NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure\n* Active infection or unexplained fever\n* Known hypersensitivity to any of the components of MM-398 or other liposomal products\n* Recent Investigational therapy\n* Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy at the time of enrollment","ALL","12 Months","20 Years",{"count":136,"type":137},30,"ESTIMATED","INTERVENTIONAL",[140],"PHASE1","This is a Phase 1 study of the combination of two drugs: MM-398 and Cyclophosphamide. The goal is to find the highest dose of MM-398 that can be given safely when it is used together with the chemotherapy drug Cyclophosphamide.",[143,144,145,146,147],"Recurrent or Refractory Solid Tumors","Ewing Sarcoma","Rhabdomyosarcoma","Neuroblastoma","Osteosarcoma",[149,150,151,152],"pediatric","MM-398","cyclophosphamide","irinotecan","2026-10-05",{"date":155,"type":156},"2026-10-08","ACTUAL",{"date":158,"type":156},"2013-12",{"date":160,"type":137},"2027-03",{"name":5,"class":6},5]