Trabectedin + Irinotecan for Ewing Sarcoma
(U01CA236220 Trial)
What You Need to Know Before You Apply
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.
Who Is on the Research Team?
Patrick Grohar, MD
Principal Investigator
Children's Hospital of Philadelphia
John Glod, MD/PhD
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
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 β₯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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Trabectedin administered as a 1-hour infusion followed by irinotecan infusions on day 2 and day 4 of 21-day cycles
Phase II Treatment
Trabectedin and irinotecan combination treatment with 18F-FLT PET imaging to evaluate treatment effect
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Irinotecan
- Trabectedin
Irinotecan is already approved in United States, European Union, Japan, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sarcoma Alliance for Research through Collaboration
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
National Institutes of Health (NIH)
Collaborator
Janssen Scientific Affairs, LLC
Industry Sponsor
Joaquin Duato
Janssen Scientific Affairs, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Scientific Affairs, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University