Combination therapy with MM-398 liposome irinotecan and cyclophosphamide in children with solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 dose-escalation trial evaluating the safety and tolerability of MM-398 combined with cyclophosphamide in pediatric patients with recurrent or refractory solid tumors, including Ewing sarcoma, rhabdomyosarcoma, neuroblastoma, and osteosarcoma. The study enrolls patients aged 12 months to under 21 years and uses gradual increases in the MM-398 dose to identify the maximum tolerated dose when paired with cyclophosphamide. Eligible participants must have measurable disease, adequate organ function, and recovery from prior therapies, with appropriate consent/assent obtained. Primary objectives focus on safety, dose-limiting toxicities, and determining a recommended dose for future trials; preliminary activity may be observed as a secondary consideration.

Why it matters

Who can join: the full rules

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

Where it's running

• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• University Of Oklahoma Health Sciences Center
  Oklahoma City, Oklahoma, United States Recruiting
• UT Southwestern
  Dallas, Texas, United States Recruiting
• Texas Tech University Health Sciences Center
  Lubbock, Texas, United States Recruiting
• Midwest Children's Hospital
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Study coordinator: Amanda Knight, RN, BSN
• Email: amanda.knight@ttuhsc.edu
• Phone: 806-743-2690

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.