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Metastatic Ewing Sarcoma Trial Testing Enhanced Treatment Schedule

This study is for patients with widely metastatic Ewing sarcoma (cancer that has spread) or metastatic CIC-rearranged sarcoma. It's testing a new way to give existing chemotherapy drugs: Vincristine, Doxorubicin, Cyclophosphamide, Ifosfamide, and Actinomycin. The goal is to see if this enhanced schedule, which involves an intense initial treatment followed by sequential treatments and a long period of maintenance chemotherapy, is safe and possible to give. Researchers are hoping this approach can better eliminate cancer cells. The study plans to enroll 15 participants aged 1 year and older who are healthy enough for treatment. The study's status is currently unclear.

Study design
This is a single-arm study, meaning all participants receive the same treatment. It plans to enroll 15 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will assess feasibility and safety during consolidation and maintenance phases, both measured at 16 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07194044

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

Recruiting
PHASE1Ages 1+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~15 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:VincristineDoxorubicinCyclophosphamideIfosfamideActinomycinIrinotecan

At a glance

Recruiting sites
12 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility and Safety - Consolidation
Measured over 16 months
+1 more outcome measured

Conditions

Metastatic Ewing Sarcoma

Explore related trials

CIC-Rearranged SarcomaEwing Sarcoma

Where it's being run

20 sites across 11 states
Florida5
North Carolina3
New York2
Ohio2
Tennessee2
Alabama1
Arizona1
Connecticut1

Study leadership

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

Who to contact

Jessica Crimella
[email protected]
813-745-6250
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Feasibility and Safety - Consolidation16 months

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

  • Feasibility and Safety - Maintenance16 months

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