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Status unknownNCT02013336Updated Mar 31, 2022

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

A Phase 1 interventional study of MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide in Recurrent or Refractory Solid Tumors, Ewing Sarcoma and Rhabdomyosarcoma, sponsored by South Plains Oncology Consortium. Status unknown at 6 sites in United States. Open to participants aged 12 Months to 20 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by South Plains Oncology Consortium · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
12 Months to 20 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Recurrent or Refractory Solid Tumors
  • Ewing Sarcoma
  • Rhabdomyosarcoma
  • Neuroblastoma
  • Osteosarcoma

Keywords

  • pediatric
  • MM-398
  • cyclophosphamide
  • irinotecan
03

In context

Neuroblastoma

625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.

This study's planned enrollment of 30 is close to the median of 32 across 475 interventional studies indexed under Neuroblastoma.

Browse Neuroblastoma studies →

Lead sponsor

South Plains Oncology Consortium is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    MM-398 + cyclophosphamide

    MM-398+cyclophosphamide

    Drug: MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide

Interventions

  • DrugMM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide

    chemotherapy

06

What researchers measure

Primary outcomes

  1. To determine the Maximum Tolerated Dose (MTD) of MM-398 in combination with intravenous cyclophosphamide by assessing the occurrence of dose limiting toxicities

    Time frame: 12 months

Secondary outcomes

  1. Measurement of plasma levels of study drug to determine the pharmacokinetic properties of MM-398 in combination with cyclophosphamide

    Time frame: 12 months

07

Study locations

6 of 6 sites recruiting
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
    • · Contact · 513-636-4200
    • Joseph Pressey, MD · Principal investigator
    Recruiting
  • University Of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
    • Haley Jones · Contact
    Recruiting
  • UT Southwestern
    Dallas, Texas 75235, United States
    • Alison Patterson · Contact
    Recruiting
  • MD Anderson Children's Cancer Hospital
    Houston, Texas 77030, United States
    • Jonathan Gill, MD · Contact
    Recruiting
  • Texas Tech University Health Sciences Center
    Lubbock, Texas 79430, United States
    • Angie Cervantez · Contact
    Recruiting
  • Midwest Children's Hospital
    Milwaukee, Wisconsin 53226, United States
    • Olivia Tarnowske · Contact
    Recruiting
08

References and documents

Publications

  • Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. PubMed 31401903 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02013336
Lead sponsor
South Plains Oncology Consortium
Responsible party
Sponsor
First posted
Dec 17, 2013
Start date
Dec 2013
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Mar 31, 2022

Study contacts

Amanda Knight, RN, BSN
Contact
amanda.knight@ttuhsc.edu
806-743-2690
Paul Harker-Murray, MD
study chair · Midwest Children's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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