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NCT07194044RecruitingPhase 1

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
15 (estimated)
First submitted
17 Sept 2025
Start date
Feb 2026
Primary completion date
Oct 2030
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
NCT number
NCT07194044

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 15
  • From Feb 2026 to the primary completion date, Oct 2030
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who are receiving any other investigational agents for their cancer.
  • Patients must not be receiving any additional medicines being given for the specific purpose of treating cancer.

Other illness

  • Patients with localized disease or lung only metastases for Ewing sarcoma or localized disease for CIC-rearranged sarcomas.
  • Patients with a history of cancer that was treated with myelosuppressive chemotherapy or radiation therapy.
  • Patients are ineligible if they have uncontrolled intercurrent illness.

Lab values

  • 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.

Other

  • Patients with central nervous system (CNS) tumors (primary or metastatic) are not eligible.
  • Patients who are considered unable to comply with the safety monitoring requirements of the study are not eligible.

Who the study is looking for

  • 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.

Age in the registry: 1 year to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Healthcare of Atlanta - Arthur M Blank Hospital (AMBH)
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
University of Alabama at Birmingham, Children's of Alabama
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
Roswell Park Comprehensive Cancer Center
Coordinator of this site? Confirm its status
BuffaloUnited StatesRecruiting
University of North Carolina
Coordinator of this site? Confirm its status
Chapel HillUnited StatesNot yet recruiting
Levine Cancer Institute
Coordinator of this site? Confirm its status
CharlotteUnited StatesNot yet recruiting
Cleveland Clinic Children's
Coordinator of this site? Confirm its status
ClevelandUnited StatesNot yet recruiting
Nationwide Children's Hospital
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Duke University Medical Center- Children's Health Center
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
University of Florida
Coordinator of this site? Confirm its status
GainesvilleUnited StatesRecruiting
Helen DeVos Children's Hospital
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesNot yet recruiting
Connecticut Children's Medical Center
Coordinator of this site? Confirm its status
HartfordUnited StatesNot yet recruiting
Nemours Jacksonville
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
University of Kentucky
Coordinator of this site? Confirm its status
LexingtonUnited StatesRecruiting
University of Miami
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
Monroe Carell Jr. Children's Hospital at Vanderbilt
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Vanderbilt University Medical Center
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Phoenix Children s Hospital
Coordinator of this site? Confirm its status
PhoenixUnited StatesRecruiting
Primary Children's Hospital
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesRecruiting
Johns Hopkins All Children's Hospital
Coordinator of this site? Confirm its status
St. PetersburgUnited StatesRecruiting
Moffitt Cancer Center
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
Montefiore Medical Center
Coordinator of this site? Confirm its status
The BronxUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.