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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02013336
Recruitment Status : Recruiting
First Posted : December 17, 2013
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
South Plains Oncology Consortium

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent or Refractory Solid Tumors Ewing Sarcoma Rhabdomyosarcoma Neuroblastoma Osteosarcoma Drug: MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors
Actual Study Start Date : December 2013
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MM-398 + cyclophosphamide
MM-398+cyclophosphamide
 Drug: MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide
chemotherapy


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Measurement of plasma levels of study drug to determine the pharmacokinetic properties of MM-398 in combination with cyclophosphamide [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   12 Months to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013336


Contacts
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Contact: Amanda Knight, RN, BSN 806-743-2690 amanda.knight@ttuhsc.edu

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact    513-636-4200      
Principal Investigator: Joseph Pressey, MD         
United States, Oklahoma
University Of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Haley Jones         
United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States, 75235
Contact: Alison Patterson         
MD Anderson Children's Cancer Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Jonathan Gill, MD         
Texas Tech University Health Sciences Center Recruiting
Lubbock, Texas, United States, 79430
Contact: Angie Cervantez         
United States, Wisconsin
Midwest Children's Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Olivia Tarnowske         
Sponsors and Collaborators
South Plains Oncology Consortium
Investigators
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Study Chair: Paul Harker-Murray, MD Midwest Children's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: South Plains Oncology Consortium
ClinicalTrials.gov Identifier: NCT02013336    
Other Study ID Numbers: SPOC-2012-001
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by South Plains Oncology Consortium:
pediatric
MM-398
cyclophosphamide
irinotecan
Additional relevant MeSH terms:
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Neuroblastoma
Osteosarcoma
Rhabdomyosarcoma
Sarcoma, Ewing
Recurrence
Disease Attributes
Pathologic Processes
Neoplasms
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Myosarcoma
Neoplasms, Muscle Tissue
Cyclophosphamide
Irinotecan
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents