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NCT Number: NCT07194044

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

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.

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Key information

Conditions

Metastatic Ewing Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Osteosarcoma Sarcoma Sarcoma, Ewing

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham (Children's of Alabama), Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vincristine

Drug

IV Push

Doxorubicin

Drug

IV

Cyclophosphamide

Drug

IV and Maintenance PO

ifosfamide

Drug

IV

Actinomycin

Drug

IV

Irinotecan

Drug

IV

Cabozantinib

Drug

PO

Topotecan

Drug

IV

Temozolomide

Drug

IV

etoposide

Drug

PO

Liposomal Doxorubicin

Drug

IV

Primary outcomes

  1. Feasibility and Safety - Consolidation

    Time frame: 16 months

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

  2. Feasibility and Safety - Maintenance

    Time frame: 16 months

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

Secondary outcomes

  1. Event-Free Survival

    Time frame: 3 years

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

  2. Off Treatment Event Free Survival

    Time frame: 3 years

    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.

  3. Overall Survival

    Time frame: 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Crimella

CONTACT

[email protected]

813-745-6250

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Pediatric Cancer Foundation

Registry information

Acronym: METTSEO

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 26, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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