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Alkylating agents
Lurbinectedin for Ewing Sarcoma (LiFFT Trial)
Phase 1 & 2
Recruiting
Led By Theodore Laetsch, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing if a drug called lurbinectedin is safe and effective at treating cancer, including Ewing sarcoma.
Who is the study for?
This trial is for people aged 10 and older with certain types of sarcoma, including Ewing Sarcoma, that have come back or didn't respond to initial treatment. Participants need measurable disease, adequate organ function, and must not be pregnant or breastfeeding. They should agree to use birth control and meet specific recovery criteria from previous treatments.
What is being tested?
The study is testing the safety and effectiveness of a drug called lurbinectedin in treating recurrent or relapsed solid tumors. It focuses on patients whose tumors have specific genetic features known as FET fusions.
What are the potential side effects?
While the trial aims to determine all side effects of lurbinectedin, potential ones based on its class may include fatigue, nausea, hair loss (alopecia), decreased appetite, constipation or diarrhea, shortness of breath (dyspnea), coughing up blood (hemoptysis), and various blood-related issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1: Complete Response or Partial Response
Phase 1: Dose Limiting Toxicities (DLTs)
Phase 1: Frequency of adverse events
+1 moreSecondary study objectives
Phase 1: Area under the concentration-time curve (AUC)
Phase 1: Duration of Response (DoR)
Phase 1: Maximum observed Plasma Concentration (Cmax)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Ewing SarcomaExperimental Treatment1 Intervention
The first part of this study is a standard 3+3 design to test the safety, tolerability and pharmacokinetic profile of lurbinectedin administered on a day 1, 4 schedule in patients with FET-fusion tumors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lurbinectedin
2022
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
721 Previous Clinical Trials
8,604,271 Total Patients Enrolled
1 Trials studying Ewing Sarcoma
30 Patients Enrolled for Ewing Sarcoma
Jazz PharmaceuticalsIndustry Sponsor
249 Previous Clinical Trials
34,879 Total Patients Enrolled
1 Trials studying Ewing Sarcoma
60 Patients Enrolled for Ewing Sarcoma
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,047 Total Patients Enrolled
1 Trials studying Ewing Sarcoma
25 Patients Enrolled for Ewing Sarcoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has returned or didn't respond to initial treatment and has a specific genetic change.My kidney function, based on creatinine levels, is within the required range for my age and gender.I do not have any severe illnesses or infections that are not under control.I have a known bleeding disorder.My Ewing sarcoma has returned or didn't respond to first treatment, and tests confirm specific genetic changes.I am not currently taking any experimental drugs or cancer treatments.I am taking medication that strongly affects liver enzyme levels.I can care for myself and am up and about more than half of my waking hours.I can care for myself and am up more than half the day.I am taking supplements that can harm my liver.My liver, kidneys, bone marrow, and heart are functioning well.I do not have active hepatitis A, B, or C.I am 10 years old or older.My disease can be measured or evaluated by tests.My kidney function is within the required range for my age and gender.I have previously been treated with trabectedin or lurbinectedin.I have cancer that has spread to my brain.I am willing to have a tumor biopsy for the study.I have at least one tumor that can be measured or seen on scans and hasn't been treated with radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Ewing Sarcoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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