NCT07194044

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Ewing Sarcoma

Interventions

Type	Name	Description
DRUG	Vincristine	IV Push
DRUG	Doxorubicin	IV
DRUG	Cyclophosphamide	IV and Maintenance PO
DRUG	Ifosfamide	IV
DRUG	Actinomycin	IV
DRUG	Irinotecan	IV
DRUG	Cabozantinib	PO
DRUG	Topotecan	IV
DRUG	Temozolomide	IV
DRUG	Etoposide	PO
DRUG	Liposomal doxorubicin	IV

Timeline

• Start date: 2026-02-01
• Primary completion: 2030-10-01
• Completion: 2030-10-01
• First posted: 2025-09-26
• Last updated: 2026-03-16

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study