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

Sponsor

South Plains Oncology Consortium (Other)

Overall Status

Recruiting

CT.gov ID

NCT02013336

Collaborator

(none)

Enrollment

Locations

Arm

120

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent or Refractory Solid Tumors Ewing Sarcoma Rhabdomyosarcoma Neuroblastoma Osteosarcoma	Drug: MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MM-398 + cyclophosphamide MM-398+cyclophosphamide	Drug: MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide chemotherapy

Arm

Intervention/Treatment

Experimental: MM-398 + cyclophosphamide

MM-398+cyclophosphamide

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

chemotherapy

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months to 20 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
2	University Of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
3	UT Southwestern	Dallas	Texas	United States	75235
4	MD Anderson Children's Cancer Hospital	Houston	Texas	United States	77030
5	Texas Tech University Health Sciences Center	Lubbock	Texas	United States	79430
6	Midwest Children's Hospital	Milwaukee	Wisconsin	United States	53226