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

South Plains Oncology Consortium

Status and phase: Unknown; Phase 1

Conditions: Osteosarcoma; Recurrent or Refractory Solid Tumors; Neuroblastoma; Rhabdomyosarcoma; Ewing Sarcoma

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

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02013336

SPOC-2012-001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 12 months to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

MM-398 + cyclophosphamide

Experimental group

Description:

MM-398+cyclophosphamide

Treatment:

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