Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

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

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

Sponsors & Collaborators

• National Pediatric Cancer Foundation

  collaborator OTHER

• H. Lee Moffitt Cancer Center and Research Institute

  lead OTHER

Principal Investigators

• Matteo Trucco, MD · Cleveland Clinic Hospital

• Jonathan Metts, MD · Moffitt Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-05

Primary Completion

2030-10-31

Completion

2030-10-31

FDA Drug

Yes

Countries

• United States

Study Locations