Recruiting
Phase 1

MM-398 & Cyclophosphamide

Sponsor:

South Plains Oncology Consortium

Code:

NCT02013336

Conditions

Recurrent or Refractory Solid Tumors

Ewing Sarcoma

Rhabdomyosarcoma

Neuroblastoma

Osteosarcoma

Eligibility Criteria

Sex: All

Age: 1 - 20

Healthy Volunteers: Not accepted

Interventions

MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide

Study Details

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.

Conditions

Recurrent or Refractory Solid Tumors

Ewing Sarcoma

Rhabdomyosarcoma

Neuroblastoma

Osteosarcoma

Study ID

NCT02013336

Start date

Dec, 2013

Status verified date

Mar, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 20

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MM-398 + cyclophosphamide

MM-398+cyclophosphamide

Interventions

MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide

chemotherapy

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Amanda Knight, RN, BSN

806-743-2690amanda.knight@ttuhsc.edu

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

513-636-4200

Principal Investigator:

Joseph Pressey, MD

University Of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

UT Southwestern

Recruiting

Dallas, Texas, United States, 75235

MD Anderson Children's Cancer Hospital

Recruiting

Houston, Texas, United States, 77030

Texas Tech University Health Sciences Center

Recruiting

Lubbock, Texas, United States, 79430

Midwest Children's Hospital

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

South Plains Oncology Consortium

Last update posted

Mar 31, 2022

Last verified

Mar, 2022

Keywords

  • pediatric
  • MM-398
  • cyclophosphamide
  • irinotecan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by South Plains Oncology Consortium on 2022-03-31.