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Radical new schedule aims to cure High-Risk ewing sarcoma

NCT ID NCT07194044

Cure Sponsor: H. Lee Moffitt Cancer Center and Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This study tests a new treatment schedule for people with metastatic Ewing sarcoma, a rare and aggressive cancer. The approach uses an intense first attack on cancer cells, followed by targeted strikes and long-term maintenance to wipe out remaining cells. The goal is a cure. The study is for patients over 1 year old who are healthy enough for the therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

CIC-rearranged sarcoma Ewing sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic Ewing sarcoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital (AMBH)

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Cleveland Clinic Children's

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Connecticut Children's Medical Center

    NOT_YET_RECRUITING

    Hartford, Connecticut, 06106, United States

  • Duke University Medical Center- Children's Health Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Helen DeVos Children's Hospital

    NOT_YET_RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Johns Hopkins All Children's Hospital

    RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Levine Cancer Institute

    NOT_YET_RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Nemours Jacksonville

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32207, United States

  • Phoenix Children's Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Primary Children's Hospital

    RECRUITING

    Salt Lake City, Utah, 84113, United States

  • Roswell Park Comprehensive Cancer Center

    NOT_YET_RECRUITING

    Buffalo, New York, 14263, United States

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

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Kentucky

    NOT_YET_RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of North Carolina

    NOT_YET_RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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