RECRUITING

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

Quick Facts

Study Start:2025-10

Study Completion:2030-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07194044

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.

Ages Eligible for Study:1 Year

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must be \>1 year of age. There is no upper age limit. * Patients, in the opinion of the enrolling investigator, must be healthy enough to tolerate protocol therapy. * Patients must have a new histologic diagnosis of either: widely metastatic Ewing sarcoma or metastatic CIC-rearranged sarcoma. * Patients must have sufficient tissue submitted (flash frozen tissue, FFPE block, or up to 10 unstained FFPE slides) for correlative testing. This may be from a primary or metastatic site. * Patients must not have received any prior systemic therapy with the exception that they may have started an initial cycle of vincristine/doxorubicin/cyclophosphamide (VDC) prior to enrollment, i.e. VDC may have been given, but not ifosfamide/etoposide (IE). * Adequate organ function. * Males and females of reproductive potential may not participate unless they have agreed to the use of, at minimum, two methods of contraception during and after treatment or abstinence. * All patients and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.	* Patients with localized disease or lung only metastases for Ewing sarcoma or localized disease for CIC-rearranged sarcomas. * Patients with central nervous system (CNS) tumors (primary or metastatic) are not eligible. * Patients who are receiving any other investigational agents for their cancer. * Patients with a history of cancer that was treated with myelosuppressive chemotherapy or radiation therapy. * Patients must not be receiving any additional medicines being given for the specific purpose of treating cancer. * Patients are ineligible if they have uncontrolled intercurrent illness. * Pregnancy or Breast Feeding: Pregnant or breast-feeding women will not be entered on this study, because there is no available information regarding human fetal or teratogenic toxicities. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to starting protocol therapy. * Patients who are considered unable to comply with the safety monitoring requirements of the study are not eligible.

Inclusion Criteria

Exclusion Criteria

* Patients must be \>1 year of age. There is no upper age limit.
* Patients, in the opinion of the enrolling investigator, must be healthy enough to tolerate protocol therapy.
* Patients must have a new histologic diagnosis of either: widely metastatic Ewing sarcoma or metastatic CIC-rearranged sarcoma.
* Patients must have sufficient tissue submitted (flash frozen tissue, FFPE block, or up to 10 unstained FFPE slides) for correlative testing. This may be from a primary or metastatic site.
* Patients must not have received any prior systemic therapy with the exception that they may have started an initial cycle of vincristine/doxorubicin/cyclophosphamide (VDC) prior to enrollment, i.e. VDC may have been given, but not ifosfamide/etoposide (IE).
* Adequate organ function.
* Males and females of reproductive potential may not participate unless they have agreed to the use of, at minimum, two methods of contraception during and after treatment or abstinence.
* All patients and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.

* Patients with localized disease or lung only metastases for Ewing sarcoma or localized disease for CIC-rearranged sarcomas.
* Patients with central nervous system (CNS) tumors (primary or metastatic) are not eligible.
* Patients who are receiving any other investigational agents for their cancer.
* Patients with a history of cancer that was treated with myelosuppressive chemotherapy or radiation therapy.
* Patients must not be receiving any additional medicines being given for the specific purpose of treating cancer.
* Patients are ineligible if they have uncontrolled intercurrent illness.
* Pregnancy or Breast Feeding: Pregnant or breast-feeding women will not be entered on this study, because there is no available information regarding human fetal or teratogenic toxicities. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to starting protocol therapy.
* Patients who are considered unable to comply with the safety monitoring requirements of the study are not eligible.

Contacts and Locations

Study Contact

Jessica Crimella

CONTACT

813-745-6250

Jessica.Crimella@moffitt.org

Principal Investigator

Matteo Trucco, MD

PRINCIPAL_INVESTIGATOR

Cleveland Clinic Hospital

Jonathan Metts, MD

PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Study Locations (Sites)

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

Birmingham, Alabama, 35233

United States

Phoenix Children's Hospital

Phoenix, Arizona, 85016

United States

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

United States

University of Florida

Gainesville, Florida, 32610

United States

Nemours Jacksonville

Jacksonville, Florida, 32207

United States

University of Miami

Miami, Florida, 33136

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

University of Kentucky

Lexington, Kentucky, 40536

United States

Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263

United States

Montefiore Medical Center

The Bronx, New York, 10467

United States

University of North Carolina

Chapel Hill, North Carolina, 27599

United States

Levine Cancer Institute

Charlotte, North Carolina, 28204

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Primary Children's Hospital

Salt Lake City, Utah, 84113

United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Matteo Trucco, MD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic Hospital
Jonathan Metts, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

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 Registration Dates

Study Start Date2025-10

Study Completion Date2030-10

Study Record Updates

Study Start Date2025-10

Study Completion Date2030-10

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Ewing Sarcoma