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.

Trial Details

NCT ID
NCT02013336
Phase
PHASE1
Sponsor
South Plains Oncology Consortium
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide
Locations (sample)
  • Cincinnati, Ohio, United States|39.12711,-84.51439
  • Oklahoma City, Oklahoma, United States|35.46756,-97.51643
  • Dallas, Texas, United States|32.78306,-96.80667
  • Lubbock, Texas, United States|33.57786,-101.85517
  • Milwaukee, Wisconsin, United States|43.0389,-87.90647

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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