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Phase 1 Study of MM-398 Plus Cyclophosphamide in Pediatric Solid Tumors

Trial Status: Active

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 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

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Houston
M D Anderson Cancer Center
Status: APPROVED

Trial Phase Phase I

Trial Type Treatment

Lead Organization
South Plains Oncology Consortium

  • Primary ID SPOC-2012-001
  • Secondary IDs NCI-2014-02681
  • Clinicaltrials.gov ID NCT02013336