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Intensive, sequenced chemotherapy for metastatic Ewing sarcoma

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

Phase 1 Interventional H. Lee Moffitt Cancer Center and Research Institute · NCT07194044

This tests an upfront intense 'first strike' followed by sequential 'second strikes' and prolonged maintenance chemotherapy to try to cure people with newly diagnosed widely metastatic Ewing sarcoma or metastatic CIC‑rearranged sarcoma.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment15 (estimated)
Ages1 Year and up
SexAll
SponsorH. Lee Moffitt Cancer Center and Research Institute Academic / other
Drugs / interventionschemotherapy, radiation, cyclophosphamide, doxorubicin
Locations17 sites (Birmingham, Alabama and 16 other locations)
Trial IDNCT07194044 on ClinicalTrials.gov

What this trial studies

This is a single-arm Phase 1 protocol that applies evolutionary principles to cancer treatment by using an initial intense chemotherapy 'first strike' to deplete the bulk tumor followed by planned sequential 'second strikes' aimed at resistant cell populations and a prolonged maintenance phase. Treatment uses agents commonly active in newly diagnosed Ewing sarcoma such as vincristine, doxorubicin, cyclophosphamide, ifosfamide, and actinomycin. Patients must be newly diagnosed with widely metastatic disease or metastatic CIC‑rearranged sarcoma, be older than 1 year, be fit for protocol therapy, and provide tumor tissue for correlative testing. The primary goal is to demonstrate feasibility of this radically sequenced approach with correlative studies to understand response and resistance.

Who should consider this trial

Good fit: People older than 1 year with a new diagnosis of widely metastatic Ewing sarcoma or metastatic CIC‑rearranged sarcoma who have not had prior systemic therapy beyond an optional single cycle of VDC, have adequate organ function, and can provide required tumor tissue are ideal candidates.

Not a fit: Patients who have received prior systemic therapy beyond one VDC cycle, who lack adequate organ function, or who cannot provide the required tumor tissue are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could eliminate resistant tumor cell populations and lead to long-term remission or cure in patients with widely metastatic disease.

How similar studies have performed: Adaptive or evolutionary sequencing approaches have shown limited early promise in other cancers, but this specific high‑intensity sequential strategy is largely novel and unproven in metastatic Ewing sarcoma.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Birmingham, Alabama and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Ewing Sarcoma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.