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RECRUITING
NCT07194044
PHASE1

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

This single arm study is designed to demonstrate the feasibility of a radically different approach for an exceptionally high-risk subset of MES with widely metastatic disease (WMES). We incorporate the use of evolutionary principles that apply to species and population dynamics as related to adaptation and extinction to populations of cancer cells that similarly adapt and that we are attempting to make extinct, resulting in a cure for the patient. Such principles include an initial intense first strike to deplete the bulk of the cancer cells, followed by a series of sequential second strikes towards eliminating residual, resistant populations, followed by a prolonged period of maintenance chemotherapy to eliminate any remnant cells, using agents generally regarded to be active against newly diagnosed ES.

Key Details

Gender

All

Age Range

1 Year - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-02

Completion Date

2030-10

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

DRUG

Vincristine

IV Push

DRUG

Doxorubicin

IV

DRUG

Cyclophosphamide

IV and Maintenance PO

DRUG

Ifosfamide

IV

DRUG

Actinomycin

IV

DRUG

Irinotecan

IV

DRUG

Cabozantinib

PO

DRUG

Topotecan

IV

DRUG

Temozolomide

IV

DRUG

Etoposide

PO

DRUG

Liposomal doxorubicin

IV

Locations (17)

University of Alabama at Birmingham (Children's of Alabama)

Birmingham, Alabama, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

University of Florida

Gainesville, Florida, United States

Nemours Jacksonville

Jacksonville, Florida, United States

University of Miami

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Kentucky

Lexington, Kentucky, United States

Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Cleveland Clinic Children's

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Primary Children's Hospital

Salt Lake City, Utah, United States