Trabectedin + Irinotecan for Ewing Sarcoma

(U01CA236220 Trial)

Recruiting at 5 trial locations

Overseen By SARC

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sarcoma Alliance for Research through Collaboration

Must not be taking: Trabectedin, Lurbinectedin, Irinotecan, Topotecan

Disqualifiers: Brain metastases, Bleeding diathesis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

37 Participants Needed

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Trabectedin administered as a 1-hour infusion followed by irinotecan infusions on day 2 and day 4 of 21-day cycles

Completed on 11/16/2022

3 visits per cycle (in-person)

Phase II Treatment

Trabectedin and irinotecan combination treatment with 18F-FLT PET imaging to evaluate treatment effect

Ongoing

3 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 36 months

Treatment Details

Interventions

• Irinotecan
• Trabectedin

Trial Overview The 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

Group I: Trabectedin and Irinotecan Experimental Treatment 4 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 United States, European Union, Japan, Canada for the following indications:

Approved in United States as Camptosar for:

• Colorectal cancer

Approved in European Union as Irinotecan for:

• Colorectal cancer

Approved in Japan as Topotecin for:

• Colorectal cancer
• Small cell lung cancer

Approved in Canada as Irinotecan for:

• Colorectal cancer

Who Is Running the Clinical Trial?

Sarcoma Alliance for Research through Collaboration

Lead Sponsor

Trials

26

Recruited

2,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2023

MD