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

• ClinicalTrials.gov Identifier: NCT02013336
• Recruitment Status: Recruiting
• First Posted: December 17, 2013
• Last Update Posted: March 31, 2022
• Sponsor: South Plains Oncology Consortium
• Information provided by (Responsible Party): South Plains Oncology Consortium

Tracking Information

• First Submitted Date: December 11, 2013
• First Posted Date: December 17, 2013
• Last Update Posted Date: March 31, 2022
• Actual Study Start Date: December 2013
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 11, 2013): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: December 11, 2013): Measurement of plasma levels of study drug to determine the pharmacokinetic properties of MM-398 in combination with cyclophosphamide [ Time Frame: 12 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors
• Official Title: Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

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

chemotherapy

Study Arms

Experimental: MM-398 + cyclophosphamide

MM-398+cyclophosphamide

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

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 11, 2013): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Months to 20 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02013336
• Other Study ID Numbers: SPOC-2012-001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: South Plains Oncology Consortium
• Original Responsible Party: Merrimack Pharmaceuticals
• Current Study Sponsor: South Plains Oncology Consortium
• Original Study Sponsor: Merrimack Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Chair: Paul Harker-Murray, MD; Midwest Children's Hospital

• PRS Account: South Plains Oncology Consortium
• Verification Date: March 2022