Who is eligible for clinical trial NCT07194044?

Participants must meet the protocol's inclusion criteria for Metastatic Ewing Sarcoma. The stated age range is 1 Year. Confirm all requirements with the study coordinator.

Does clinical trial NCT07194044 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-26

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes (NCT07194044)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: H. Lee Moffitt Cancer Center and Research Institute

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (9 items).

Location: University of Alabama at Birmingham (Children's of Alabama) — Birmingham, Alabama

Age range: 1 Year

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (20 Sites)

University of Alabama at Birmingham (Children's of Alabama) — Birmingham, Alabama
Phoenix Children's Hospital — Phoenix, Arizona
Connecticut Children's Medical Center — Hartford, Connecticut
University of Florida — Gainesville, Florida
Nemours Jacksonville — Jacksonville, Florida
University of Miami — Miami, Florida
Johns Hopkins All Children's Hospital — St. Petersburg, Florida
Moffitt Cancer Center — Tampa, Florida
University of Kentucky — Lexington, Kentucky
Helen DeVos Children's Hospital — Grand Rapids, Michigan
Roswell Park Comprehensive Cancer Center — Buffalo, New York
Montefiore Medical Center — The Bronx, New York
University of North Carolina — Chapel Hill, North Carolina
Levine Cancer Institute — Charlotte, North Carolina
Duke University Medical Center- Children's Health Center — Durham, North Carolina
Cleveland Clinic Children's — Cleveland, Ohio
Nationwide Children's Hospital — Columbus, Ohio
Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee
Vanderbilt University Medical Center — Nashville, Tennessee
Primary Children's Hospital — Salt Lake City, Utah

📞 Contact the Study Coordinator

Phone: (813) 745-6250

Email: Jessica.Crimella@moffitt.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Metastatic Ewing Sarcoma

Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma — Birmingham, Alabama

Explore by condition: All Metastatic Ewing Sarcoma clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗