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Recruiting nowPhase 1Ages 1 Year and up

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

Sponsor: H. Lee Moffitt Cancer Center and Research Institute · NCT07194044 on ClinicalTrials.gov ↗

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Conditions studied

Metastatic Ewing Sarcoma

What it tests

  • Vincristinedrug
  • Doxorubicindrug
  • Cyclophosphamidedrug
  • Ifosfamidedrug
  • Actinomycindrug
  • Irinotecandrug
  • Cabozantinibdrug
  • Topotecandrug
  • Temozolomidedrug
  • Etoposidedrug
  • Liposomal doxorubicindrug

Where it's running17 sites

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

    Birmingham, Alabama 35233

    Recruiting now
    • Elizabeth Alva, MD(principal investigator)

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016

    Opening soon
    • Mona Nourani, DO(principal investigator)

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106

    Opening soon
    • Michael Isakoff, MD(principal investigator)

  • University of Florida

    Gainesville, Florida 32610

    Recruiting now
    • Joanne Lagmay, MD(principal investigator)

  • Nemours Jacksonville

    Jacksonville, Florida 32207

    Opening soon
    • Anderson Collier III, MD(principal investigator)

  • University of Miami

    Miami, Florida 33136

    Recruiting now

  • Moffitt Cancer Center

    Tampa, Florida 33612

    Recruiting now
    • Jonathan Metts, MD(principal investigator)
    • Mihaela Druta, MD(sub investigator)
    • Andrew Brohl, MD(sub investigator)
    • Mauricio Silva Almeida Ribeiro, MD(sub investigator)
    • Isabel Canizares, APRN(sub investigator)
    • Desiree Morales, APRN(sub investigator)
    • Rikesh Makanji, MD(sub investigator)
    • Nataranjan Raghunand, MD(sub investigator)
    • Arash Naghavi, MD(sub investigator)

  • University of Kentucky

    Lexington, Kentucky 40536

    Opening soon
    • Thomas Badgett, MD(principal investigator)

  • Helen DeVos Children's Hospital

    Grand Rapids, Michigan 49503

    Opening soon
    • David Hoogstra, MD(principal investigator)

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14263

    Opening soon
    • Ajay Gupta, MD(principal investigator)

  • Montefiore Medical Center

    The Bronx, New York 10467

    Opening soon
    • Alice Lee, MD(principal investigator)

  • University of North Carolina

    Chapel Hill, North Carolina 27599

    Opening soon
    • Patrick Thompson, MD(principal investigator)

  • Levine Cancer Institute

    Charlotte, North Carolina 28204

    Opening soon
    • Erin Trovillion, MD(principal investigator)

  • Cleveland Clinic Children's

    Cleveland, Ohio 44195

    Opening soon
    • Matteo Trucco, MD(principal investigator)

  • Nationwide Children's Hospital

    Columbus, Ohio 43205

    Recruiting now
    • Bhuvana Setty, MD(principal investigator)

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232

    Opening soon
    • Scott Borinstein, MD(principal investigator)

  • Primary Children's Hospital

    Salt Lake City, Utah 84113

    Opening soon
    • Matthew Dietz, DO(principal investigator)
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

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.

Updated 2026-05-15 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.