Actively Recruiting
Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-16
15
Participants Needed
17
Research Sites
243 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
N
National Pediatric Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be >1 year of age with no upper age limit.
- Patients must be healthy enough to tolerate the treatment as judged by the enrolling investigator.
- Patients must have a new histologic diagnosis of widely metastatic Ewing sarcoma or metastatic CIC-rearranged sarcoma.
- Patients must provide sufficient tissue sample for correlative testing from either primary or metastatic sites.
- Patients must not have received prior systemic therapy except possibly one initial cycle of vincristine/doxorubicin/cyclophosphamide but not ifosfamide/etoposide.
- Patients must have adequate organ function.
- Patients of reproductive potential must agree to use at least two methods of contraception or abstinence during and after treatment.
- Patients and/or their guardians must understand and be willing to sign informed consent or assent.
You will not qualify if you...
- Patients with localized disease or lung-only metastases for Ewing sarcoma, or localized disease for CIC-rearranged sarcomas.
- Patients with central nervous system tumors, either primary or metastatic.
- Patients receiving other investigational cancer treatments.
- Patients with a history of cancer treated with myelosuppressive chemotherapy or radiation.
- Patients receiving additional medicines specifically to treat cancer.
- Patients with uncontrolled intercurrent illness.
- Pregnant or breastfeeding women; females of childbearing potential must have a negative pregnancy test within 72 hours before starting treatment.
- Patients unable to comply with safety monitoring requirements of the study.
AI-Screening
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Trial Site Locations
Total: 17 locations
1
University of Alabama at Birmingham (Children's of Alabama)
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Not Yet Recruiting
3
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Not Yet Recruiting
4
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
5
Nemours Jacksonville
Jacksonville, Florida, United States, 32207
Not Yet Recruiting
6
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
7
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
8
University of Kentucky
Lexington, Kentucky, United States, 40536
Not Yet Recruiting
9
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Not Yet Recruiting
10
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Not Yet Recruiting
11
Montefiore Medical Center
The Bronx, New York, United States, 10467
Not Yet Recruiting
12
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Not Yet Recruiting
13
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Not Yet Recruiting
14
Cleveland Clinic Children's
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
15
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
16
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
17
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Not Yet Recruiting
Research Team
J
Jessica Crimella
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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