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

Neuroblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02013336
• Other study ID #: SPOC-2012-001
• Status: Recruiting
• Phase: Phase 1
• Start date: December 2013
• Est. completion date: December 2023

Study information

• Verified date: March 2022
• Source: South Plains Oncology Consortium
• Contact: Amanda Knight, RN, BSN
• Phone: 806-743-2690
• Email: amanda.knight[@]ttuhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 20 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
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	University Of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
South Plains Oncology Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the Maximum Tolerated Dose (MTD) of MM-398 in combination with intravenous cyclophosphamide by assessing the occurrence of dose limiting toxicities		12 months
Secondary	Measurement of plasma levels of study drug to determine the pharmacokinetic properties of MM-398 in combination with cyclophosphamide		12 months