Status:
RECRUITING
Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
National Pediatric Cancer Foundation
Conditions:
Metastatic Ewing Sarcoma
Eligibility:
All Genders
1+ years
Phase:
PHASE1
Brief 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). We incorporate th...
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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07194044
Start Date
December 1 2025
End Date
October 1 2030
Last Update
December 16 2025
Active Locations (17)
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1
University of Alabama at Birmingham (Children's of Alabama)
Birmingham, Alabama, United States, 35233
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
4
University of Florida
Gainesville, Florida, United States, 32610