Trabectedin + Irinotecan for Ewing Sarcoma
(U01CA236220 Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byPatrick Grohar, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Sarcoma Alliance for Research through Collaboration

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study evaluates the trabectedin and irinotecan in the treatment of Ewings sarcoma, with a EWS-FLI1 mutation. Patients will also receive an infusion of 18F-FLT in combination with a Positron Emission Tomography (PET) scan to help evaluate the effect of treatment. Phase I was completed on 11/16/2022. Phase II is actively recruiting.

Research Team

Patrick Grohar, MD

Principal Investigator

Children's Hospital of Philadelphia

John Glod, MD/PhD

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for patients with relapsed and refractory Ewing sarcoma, specifically the EWS-FLI1 fusion type. Participants must have measurable disease, be in a relatively stable condition (ECOG 0-2 or Lansky ≥50), and agree to undergo tumor biopsies. They should not be pregnant or breastfeeding, have no known therapy that prolongs survival, and must not have used certain drugs like trabectedin.

Inclusion Criteria

Written, voluntary consent

I am willing to have a tumor biopsy.

My organs are working well.

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Exclusion Criteria

You have had an allergic reaction in the past to irinotecan or topotecan or any substances they contain.

Pregnant or breastfeeding

Unable to comply with the safety monitoring requirements

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Treatment Details

Interventions

Irinotecan (Topoisomerase I inhibitors)
Trabectedin (Alkylating agents)

Trial OverviewThe study tests trabectedin combined with irinotecan for treating Ewing sarcoma. It includes an infusion of a diagnostic agent (18F-FLT) followed by PET scans to assess treatment effects. The first phase has been completed; the second phase is now recruiting participants to further evaluate safety and efficacy.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Trabectedin and IrinotecanExperimental Treatment4 Interventions

Trabectedin will be delivered by infusion on day 1 followed by 2 doses on irinotecan delivered by infusion for one hour on day 2 and day 4 of 21 day cycles. Some patients will receive an 18F-FLT Imaging scan prior to the first administration of trabectedin and once after administration of trabectedin.

Irinotecan is already approved in Japan, Canada for the following indications: