HOW CAN WE HELP YOU? Call 1-800-TRY-CHOP
Lurbinectedin in Ewing Sarcoma
This study is now recruiting.
This study involves taking a study drug called lurbinectedin. The overall goal of this study is to see if different doses of lurbinectedin are safe and effective at treating children and young adults with recurrent or relapsed solid tumors, including Ewing Sarcoma.
Who Do I Contact?
If you are interested in participating in the study or want to learn more please contact our study team at CancerTrials [at] chop.edu or 267-425-5544.
Eligibility & Criteria
IRB #:
22-020296
Official Title:
A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants with Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants with Relapsed/Refractory Ewing Sarcoma
Study Phase:
Phase I
Phase II
Eligible Age Range:
2 - 30 Years
Gender:
All
Visit Criteria
This study has several phases. Phase 1, Part 1 will enroll male and female patients between 2 and 18 years of age with solid tumors that have not responded to other treatments. Phase 1, Part 2 and Phase 2 will enroll male and female patients between 2 and 30 years of age that have been diagnosed with Ewing sarcoma that has not responded to other treatments. In all phases, subjects will receive lurbinectedin via intravenous infusion.
Study visits include the following assessments: blood draws and optional tissue collection (if a tumor biopsy is performed as part of regular clinical care). Reimbursement for travel/meal expenses may be provided. In addition to the study visits, subjects will need to come to CHOP frequently for assessments as part of regular cancer care. This includes follow-up visits, blood draws, and scans to monitor any side effects and tumor response.
Leader
