Clareo Health | Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors
Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors
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
Adequate bone marrow reserves, hepatic function, and renal function
Recovered from effects of any prior surgery or cancer therapy
Patients 18 years or older will provide written consent. A parent or legal guardian of a patient \<18 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.
You may not be if
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
Recent Investigational therapy
Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy at the time of enrollment
