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

March 17, 2022 updated by: South Plains Oncology Consortium
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
          • Phone Number: 513-636-4200
        • Principal Investigator:
          • Joseph Pressey, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
          • Haley Jones
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • UT Southwestern
        • Contact:
          • Alison Patterson
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Children's Cancer Hospital
        • Contact:
          • Jonathan Gill, MD
      • Lubbock, Texas, United States, 79430
        • Recruiting
        • Texas Tech University Health Sciences Center
        • Contact:
          • Angie Cervantez
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Midwest Children's Hospital
        • Contact:
          • Olivia Tarnowske

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of plasma levels of study drug to determine the pharmacokinetic properties of MM-398 in combination with cyclophosphamide
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Plains Oncology Consortium

Investigators

  • Study Chair: Paul Harker-Murray, MD, Midwest Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPOC-2012-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteosarcoma

Clinical Trials on MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe