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

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ClinicalTrials.gov Identifier: NCT02013336
Recruitment Status : Recruiting
First Posted : December 17, 2013
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
South Plains Oncology Consortium

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : December 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


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



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 ]


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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

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

Locations
United States, Oklahoma
University Of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States
Contact: Susan Heavner         
United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States
Contact: Alison Patterson         
Not yet recruiting
Houston, Texas, United States
Texas Tech University Health Sciences Center Not yet recruiting
Lubbock, Texas, United States, 79430
United States, Wisconsin
Midwest Children's Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Adam Fiebelkorn         
Sponsors and Collaborators
South Plains Oncology Consortium
Investigators
Study Chair: Paul Harker-Murray, MD Midwest Children's Hospital

Responsible Party: South Plains Oncology Consortium
ClinicalTrials.gov Identifier: NCT02013336     History of Changes
Other Study ID Numbers: SPOC-2012-001
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

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:
Neuroblastoma
Osteosarcoma
Rhabdomyosarcoma
Sarcoma, Ewing
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Myosarcoma
Neoplasms, Muscle Tissue
Cyclophosphamide
Irinotecan
Camptothecin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents