Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors
South Plains Oncology Consortium
Summary
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.
Eligibility
- Age range
- 1–20 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 year…
Interventions
- DrugMM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide
chemotherapy
Locations (5)
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- University Of Oklahoma Health Sciences CenterOklahoma City, Oklahoma
- UT SouthwesternDallas, Texas
- Texas Tech University Health Sciences CenterLubbock, Texas
- Midwest Children's HospitalMilwaukee, Wisconsin