RecruitingPhase 1NCT07194044

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

15 participants

Start Date

Feb 5, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This trial (METTTSE) is testing an enhanced chemotherapy schedule for patients with newly diagnosed widely metastatic Ewing sarcoma or a related bone cancer called CIC-rearranged sarcoma, to see if changing the timing of drug delivery can improve outcomes. **You may be eligible if...** - You are older than 1 year of age (there is no upper age limit) - You have a new histologic diagnosis of widely metastatic Ewing sarcoma or metastatic CIC-rearranged sarcoma - You are healthy enough in your doctor's opinion to tolerate the study treatment - You have enough tumor tissue available for lab testing - You have not yet received systemic therapy, OR you have only received the first cycle of VDC (vincristine, doxorubicin, cyclophosphamide) prior to enrollment **You may NOT be eligible if...** - You have previously received more than one cycle of chemotherapy or any ifosfamide/etoposide (IE) - Your organ function does not meet the required thresholds - Your cancer is not widely metastatic Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVincristine

IV Push

DRUGDoxorubicin

IV

DRUGCyclophosphamide

IV and Maintenance PO

DRUGIfosfamide

IV

DRUGActinomycin

IV

DRUGIrinotecan

IV

DRUGCabozantinib

PO

DRUGTopotecan

IV

DRUGTemozolomide

IV

DRUGEtoposide

PO

DRUGLiposomal 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

View Full Details on ClinicalTrials.gov

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NCT07194044