Phase 1 Study of MM-398 Plus Cyclophosphamide in Pediatric Solid Tumors



Status:Recruiting
Conditions:Cancer, Cancer, Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 20
Updated:8/26/2018
Start Date:December 2013
End Date:December 2020
Contact:Amanda Knight, RN, BSN, CCRP
Email:amanda.knight@ttuhsc.edu
Phone:806-743-2690

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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.


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
We found this trial at
6
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Joseph Pressey, MD
Phone: 513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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Dallas, Texas 75390
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Dallas, TX
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Houston, TX
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Milwaukee, Wisconsin 53226
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Milwaukee, WI
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Oklahoma City, OK
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