Phase 1 Study of MM-398 Plus Cyclophosphamide in Pediatric Solid Tumors
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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.
Condition or disease
Recurrent or Refractory Solid TumorsEwing SarcomaRhabdomyosarcomaNeuroblastomaOsteosarcoma
Drug: MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide
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Ages Eligible for Study:
12 Months to 20 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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