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NCT07194044 · ClinicalTrials.gov registry record · Phase 1
Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes
A Phase 1 study of Metastatic Ewing Sarcoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 17
- Study locations
NCT07194044: Recruiting Phase 1 study of Metastatic Ewing Sarcoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT07194044 is a Phase 1 study of Metastatic Ewing Sarcoma that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 15 participants, below the 256-participant average among 3 other Metastatic Ewing Sarcoma trials with a reported enrollment target (94% lower). The trial reports 17 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07194044, a Phase 1 study of Metastatic Ewing Sarcoma, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 17
- Study locations
Study 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 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.
Primary Outcome
The treatment will be considered feasible if 70% of Ewing sarcoma patients make it through consolidation.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Vincristine
- DRUG Ifosfamide
- DRUG Actinomycin
Study Locations (17)
Florida
- University of Florida - Gainesville
- Nemours Jacksonville - Jacksonville
- University of Miami - Miami
- Moffitt Cancer Center - Tampa
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Montefiore Medical Center - The Bronx
North Carolina
- University of North Carolina - Chapel Hill
- Levine Cancer Institute - Charlotte
Ohio
- Cleveland Clinic Children's - Cleveland
- Nationwide Children's Hospital - Columbus
Alabama
- University of Alabama at Birmingham (Children's of Alabama) - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
Connecticut
- Connecticut Children's Medical Center - Hartford
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2026-02 |
| Est. Completion | 2030-10 |
| Phase | Phase 1 |
What NCT07194044 shows while recruiting
NCT07194044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 256-participant average among 3 other Metastatic Ewing Sarcoma trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Metastatic Ewing Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT07194044 lists 17 locations in 11 states (Florida, New York, North Carolina).
Frequently Asked Questions
What is clinical trial NCT07194044 about?
NCT07194044 is a clinical study titled "Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes". 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 adaptat...
What is the current status of trial NCT07194044?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2026-02. Estimated completion is 2030-10.
What conditions does trial NCT07194044 study?
This clinical trial studies the following conditions: Metastatic Ewing Sarcoma.
What interventions are being tested in trial NCT07194044?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Vincristine (DRUG), Ifosfamide (DRUG), Actinomycin (DRUG).
Who is sponsoring clinical trial NCT07194044?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07194044 being conducted?
This trial has 17 study locations across Alabama, Arizona, Connecticut, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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