RecruitingPhase 1Phase 2NCT05918640

Lurbinectedin in FET-Fused Tumors

Lurbinectedin in FET-Fusion Tumors (LIFFT)


Sponsor

Children's Hospital of Philadelphia

Enrollment

63 participants

Start Date

Jul 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to find out if a drug called lurbinectedin (the "study drug") is safe and effective at treating people with recurrent or relapsed solid tumors, including Ewing sarcoma.


Eligibility

Min Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called lurbinectedin in patients with rare cancers that have a specific genetic feature called a FET gene fusion — including Ewing sarcoma (a bone and soft tissue cancer) and other solid tumors with related gene rearrangements. These cancers have come back or stopped responding to standard treatments. The trial has two phases: a dose-finding phase and an efficacy-testing phase focused on Ewing sarcoma. **You may be eligible if:** - You are 10 years or older - Your cancer has returned or stopped responding to standard treatment - Your tumor has been confirmed to have a FET gene fusion (involving EWSR1, FUS, or TAF15 genes) by genetic testing - You are physically functional enough to carry out self-care activities (ECOG 0-1, or Lansky score at least 70 for children under 16) - You have at least one measurable tumor on imaging within the past 28 days **You may NOT be eligible if:** - Your cancer has not been confirmed to have a FET gene fusion - Your overall health or organ function does not meet the study's requirements - You are unable to tolerate the study treatment based on medical evaluation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLurbinectedin

Lurbinectedin will be administered on a Day 1, Day 4 schedule every 21 days. Doses will be determined in the phase 1 portion of the trial.


Locations(6)

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT05918640


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