Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors

  • STATUS
    Recruiting
  • End date
    Dec 21, 2023
  • participants needed
    30
  • sponsor
    South Plains Oncology Consortium
Updated on 21 April 2022
renal function
cancer
cyclophosphamide
bone marrow procedure
kidney function tests
irinotecan
cancer chemotherapy
solid tumour
solid tumor
sarcoma
ewing's sarcoma

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.

Details
Condition Recurrent or Refractory Solid Tumors, Ewing Sarcoma, Rhabdomyosarcoma, Neuroblastoma, Osteosarcoma
Treatment MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide
Clinical Study IdentifierNCT02013336
SponsorSouth Plains Oncology Consortium
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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