NCT02013336RecruitingPhase 1
Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 11 Dec 2013
- Start date
- Dec 2013
- Primary completion date
- Dec 2026
- Lead sponsor
- South Plains Oncology Consortium
- Diseases
- Neuroblastoma, Childhood cancers, Sarcoma
- NCT number
- NCT02013336
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From Dec 2013 to the primary completion date, Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent Investigational therapy
Other illness
- 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
Other
- Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy at the time of enrollment
Who the study is looking for
- 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.
Age in the registry: 12 months to 20 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| UT Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Texas Tech University Health Sciences Center Coordinator of this site? Confirm its status | Lubbock | United States | Recruiting |
| Midwest Children's Hospital Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.