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

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merrimack Pharmaceuticals; South Plains Oncology Consortium
• Collaborator: South Plains Oncology Consortium
• Treatments: Camptothecin; Cyclophosphamide; Irinotecan

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