Neuroblastoma Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Months to 20 Years |
Eligibility | 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 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | UT Southwestern | Dallas | Texas |
United States | MD Anderson Children's Cancer Hospital | Houston | Texas |
United States | Texas Tech University Health Sciences Center | Lubbock | Texas |
United States | Midwest Children's Hospital | Milwaukee | Wisconsin |
United States | University Of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
South Plains Oncology Consortium |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the Maximum Tolerated Dose (MTD) of MM-398 in combination with intravenous cyclophosphamide by assessing the occurrence of dose limiting toxicities | 12 months | ||
Secondary | Measurement of plasma levels of study drug to determine the pharmacokinetic properties of MM-398 in combination with cyclophosphamide | 12 months |
Status | Clinical Trial | Phase | |
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