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.
Histologically or cytologically-confirmed Ewing sarcoma, rhabdomyosarcoma, neuroblastoma, or osteosarcoma
Disease progression after prior therapy in locally advanced or metastatic setting
Measurable or evaluable disease based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria
Age 12 months to <21 years
Clinically significant gastrointestinal disorders
NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
Active infection or unexplained fever
Known hypersensitivity to any of the components of MM-398 or other liposomal products
Single group
MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide
Drugchemotherapy
To determine the Maximum Tolerated Dose (MTD) of MM-398 in combination with intravenous cyclophosphamide by assessing the occurrence of dose limiting toxicities
Measurement of plasma levels of study drug to determine the pharmacokinetic properties of MM-398 in combination with cyclophosphamide
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