Intensive, sequenced chemotherapy for metastatic Ewing sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham (Children's of Alabama)
  Birmingham, Alabama, United States Recruiting
• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting
• Nemours Jacksonville
  Jacksonville, Florida, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• Johns Hopkins All Children's Hospital
  St. Petersburg, Florida, United States Recruiting

Study contacts

• Principal investigator: Matteo Trucco, MD — Cleveland Clinic Hospital
• Study coordinator: Jessica Crimella
• Email: Jessica.Crimella@moffitt.org
• Phone: 813-745-6250

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.