NCT02013336

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2013

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

10 years

First QC Date

December 11, 2013

Last Update Submit

March 17, 2022

Conditions

Recurrent or Refractory Solid TumorsEwing SarcomaRhabdomyosarcomaNeuroblastomaOsteosarcoma

Keywords

pediatricMM-398cyclophosphamideirinotecan

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Measurement of plasma levels of study drug to determine the pharmacokinetic properties of MM-398 in combination with cyclophosphamide

    12 months

Study Arms (1)

MM-398 + cyclophosphamide

EXPERIMENTAL

MM-398+cyclophosphamide

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

Interventions

MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamideDRUG

chemotherapy

MM-398 + cyclophosphamide

Eligibility Criteria

Age12 Months - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

University Of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

UT Southwestern

Dallas, Texas, 75235, United States

RECRUITING

MD Anderson Children's Cancer Hospital

Houston, Texas, 77030, United States

RECRUITING

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

RECRUITING

Midwest Children's Hospital

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (1)

  • Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.

    PMID: 31401903DERIVED

MeSH Terms

Conditions

RecurrenceSarcoma, EwingRhabdomyosarcomaNeuroblastomaOsteosarcoma

Interventions

irinotecan sucrosofate

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcomaMyosarcomaNeoplasms, Muscle TissueNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Paul Harker-Murray, MD

    Midwest Children's Hospital

    STUDY CHAIR

Central Study Contacts

Amanda Knight, RN, BSN

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2013

First Posted

December 17, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

US(6)