Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors
Status unconfirmed · Phase 1
Conditions studied: Recurrent or Refractory Solid Tumors, Ewing Sarcoma, Rhabdomyosarcoma, Neuroblastoma, Osteosarcoma
In brief
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.
Key facts
- Study ID
- NCT02013336
- Run by
- South Plains Oncology Consortium
- People needed
- 30
- Starts
- 2013-12-01
- Expected to finish
- 2023-12-01
- Last updated by the study team
- 2022-03-31
Who can join
Age: 1 and older, up to 20. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 qualify 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
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- University Of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
- UT Southwestern — Dallas, Texas, United States (enrolling)
- MD Anderson Children's Cancer Hospital — Houston, Texas, United States (enrolling)
- Texas Tech University Health Sciences Center — Lubbock, Texas, United States (enrolling)
- Midwest Children's Hospital — Milwaukee, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
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