[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"South Plains Oncology Consortium\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30],"Recurrent or Refractory Solid Tumors","Ewing Sarcoma","Rhabdomyosarcoma","Neuroblastoma","Osteosarcoma",[32,33,34,35],"pediatric","MM-398","cyclophosphamide","irinotecan","RECRUITING","2026-10-05",{"date":39,"type":40},"2026-10-08","ACTUAL",{"date":42,"type":40},"2013-12",{"date":44,"type":20},"2027-03",{"name":46,"class":47},"South Plains Oncology Consortium","NETWORK",5,""]