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

Phase 1

• Conditions: Recurrent or Refractory Solid Tumors; Ewing Sarcoma; Rhabdomyosarcoma; Neuroblastoma; Osteosarcoma
• Interventions: Drug: MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide

• Registration Number: NCT02013336
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-31
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MM-398 + cyclophosphamide	MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide	MM-398+cyclophosphamide

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Measurement of plasma levels of study drug to determine the pharmacokinetic properties of MM-398 in combination with cyclophosphamide	12 months

Trial Locations

Locations (6)

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