NCT02013336UnknownPhase 1
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 Consortium6 sites in 1 country30 target enrollmentStarted: December 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 30
- Locations
- 6
- Primary Endpoint
- To determine the Maximum Tolerated Dose (MTD) of MM-398 in combination with intravenous cyclophosphamide by assessing the occurrence of dose limiting toxicities
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Months to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
MM-398 + cyclophosphamide
Experimental
MM-398+cyclophosphamide
Intervention: MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Measurement of plasma levels of study drug to determine the pharmacokinetic properties of MM-398 in combination with cyclophosphamide(12 months)
Investigators
Study Sites (6)
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