Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors
NCT ID: NCT02013336
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2013-12-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MM-398 + cyclophosphamide
MM-398+cyclophosphamide
MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide
chemotherapy
Interventions
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MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide
chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Months
20 Years
ALL
No
Sponsors
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South Plains Oncology Consortium
NETWORK
Responsible Party
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Principal Investigators
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Paul Harker-Murray, MD
Role: STUDY_CHAIR
Midwest Children's Hospital
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
UT Southwestern
Dallas, Texas, United States
MD Anderson Children's Cancer Hospital
Houston, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Midwest Children's Hospital
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Haley Jones
Role: primary
Alison Patterson
Role: primary
Jonathan Gill, MD
Role: primary
Angie Cervantez
Role: primary
Olivia Tarnowske
Role: primary
References
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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.
Other Identifiers
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SPOC-2012-001
Identifier Type: -
Identifier Source: org_study_id
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