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Metastatic Ewing SarcomaPhase 1METTSEONCT07194044

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

A Phase 1 study testing Vincristine, Doxorubicin and Cyclophosphamide in people with Metastatic Ewing Sarcoma, run by H. Lee Moffitt Cancer Center and Research Institute at 21 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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). Read more about this study

Who is it for?
Ages 1 year and older
Conditions the study is for
Metastatic Ewing Sarcoma
What is being tested?
Vincristine, Doxorubicin and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
21 sitesUnited States
Study dates
5 Feb 2026to Oct 2030
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jessica Crimella contact

813-745-6250

Jessica.Crimella@moffitt.org

21 sites in 1 country

United States21 sites, 21 recruiting

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

    Atlanta, Georgia, 30329

    William Cash, MD

    Recruiting

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

    Birmingham, Alabama, 35233

    Elizabeth Alva, MD

    Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

    Ajay Gupta, MD

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Patrick Thompson, MD

    Not yet recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

    Erin Trovillion, MD

    Not yet recruiting

  • Cleveland Clinic Children's

    Cleveland, Ohio, 44195

    Matteo Trucco, MD

    Not yet recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Bhuvana Setty, MD

    Recruiting

  • Duke University Medical Center- Children's Health Center

    Durham, North Carolina, 27710

    Jessica Sun, MD

    Recruiting

  • University of Florida

    Gainesville, Florida, 32610

    Joanne Lagmay, MD

    Recruiting

  • Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

    David Hoogstra, MD

    Not yet recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

    Michael Isakoff, MD

    Not yet recruiting

  • Nemours Jacksonville

    Jacksonville, Florida, 32207

    Anderson Collier III, MD

    Recruiting

  • University of Kentucky

    Lexington, Kentucky, 40536

    Thomas Badgett, MD

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Eva Pavicic, 305-585-5635, EPavicic@med.miami.edu

    Aditi Dhir, MD

    Recruiting

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232

    Scott Borinstein, MD, PhD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Scott Borinstein, MD

    Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

    Mona Nourani, DO

    Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113

    Matthew Dietz, DO

    Recruiting

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

    Blake Foxworthy, MD

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Jonathan Metts, MD

    Mihaela Druta, MD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Alice Lee, MD

    Recruiting

Other trials in United States

About this study

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.

Being tested
Vincristine, Doxorubicin, Cyclophosphamide, Ifosfamide, Actinomycin
Medical subject headings
Sarcoma, Ewing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07194044
Study groupRoleWhat they receive
Sequential TherapyExperimentalWeeks 1-8, Vincristine/Doxorubicin/Cyclophosphamide. Weeks 9-14, Irinotecan, Ifosfamide, Vincristine, Actinomycin (IrIVA). Weeks 15-20, Cabozantinib w/ primary site radiation. Weeks 21-26, Topotecan/Cyclophosphamide. Weeks 27-32, High Dose Ifosfamide. Weeks 33-38, Irinotecan/Temozolomide. Maintenance, Weeks 39 up to 104, will consist of alternating 28-day blocks of chemotherapy (Block 1 and Block 2). Oral Cyclophosphamide / Oral Etoposide (Block 1). Vincristine/ Liposomal Doxorubicin (Block 2).
Receives: Drug: Vincristine; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Ifosfamide; Drug: Actinomycin; Drug: Irinotecan; Drug: Cabozantinib; Drug: Topotecan; Drug: Temozolomide; Drug: Etoposide; Drug: Liposomal doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility and Safety - Consolidation

    The treatment will be considered feasible if 70% of Ewing sarcoma patients make it through consolidation.

    Measured: 16 months

  2. Feasibility and Safety - Maintenance

    The treatment will be considered feasible if 50% of Ewing sarcoma patients make it through 6 cycles of maintenance.

    Measured: 16 months

Secondary outcomes (3)

  1. Event-Free Survival

    EFS is defined as time from treatment initiation to event which includes (1) recurrence, (2) secondary malignancy, and (3) death due to any cause.

    Measured: 3 years

  2. Off Treatment Event Free Survival

    otEFS is defined as time from treatment initiation to event 66 which includes (1) any recurrence (local or regional, or distant) that leads to coming off protocol therapy and (2) death due to any cause.

    Measured: 3 years

  3. Overall Survival

    The time to event endpoint of overall survival is defined as the duration of time from diagnosis to death or last follow-up timepoint, where event would be death from any cause.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2025
  2. Study start5 Feb 2026
  3. Primary completionOct 2030 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07194044
Sponsor's protocol ID
MCC-23281
Acronym
METTSEO
Status last verified
Sep 2026
First submitted
17 Sep 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

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