Ewing Sarcoma, Neuroblastoma, Osteosarcoma, Recurrent or Refractory Solid Tumors, Rhabdomyosarcoma
Conditions
Keywords
pediatric, MM-398, cyclophosphamide, irinotecan
Brief 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.
Interventions
DRUGMM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide
chemotherapy
Sponsors
South Plains Oncology Consortium
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 20 Years
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Measurement of plasma levels of study drug to determine the pharmacokinetic properties of MM-398 in combination with cyclophosphamide | 12 months |
Countries
United States
Contacts
Primary ContactAmanda Knight, RN, BSN
Outcome results
None listed