Tests MM-398 with cyclophosphamide in children with hard-to-treat solid tumors
Tests MM-398 with cyclophosphamide to find a safe dose in children with recurrent solid tumors.
Plain-language title generated from the registry record
Registry title: Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors
Key facts
- Where
- Cincinnati, Dallas, Lubbock, Milwaukee, and Oklahoma City, United StatesSee the 5 sites
- Phase
- Phase 1
Where in United States
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
- UT SouthwesternDallas, United StatesTaking people
- Texas Tech University Health Sciences CenterLubbock, United StatesTaking people
- Midwest Children's HospitalMilwaukee, United StatesTaking people
- University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- South Plains Oncology Consortium
- Trial code
- NCT02013336
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors
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.
Inclusion: 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.
Exclusion: Recent Investigational therapy; 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; Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy at the time of enrollment.