SARC037: a Phase I/II Study to Evaluate the Safety of Trabectedin Administered As a 1-Hour Infusion in Ewing Sarcoma Patients in Combination with Low Dose Irinotecan and 3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging
Who is this study for? Patients with Ewings sarcoma
What treatments are being studied? Trabectedin+Irinotecan+Tumor biopsy+3'-Deoxy-3'-18F Fluorothymidine Imaging
Status: Active_not_recruiting
Location: See all (6) locations...
Intervention Type: Other, Drug, Diagnostic test
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 99
Healthy Volunteers: f
View:
• diagnosis of relapsed and refractory Ewing sarcoma with EWS-FLI1 fusion type for which there is no known therapy proving to prolong survival
• measurable disease
• ECOG Performance Status of 0-2 or Lansky of 50
• adequate organ function
• written, voluntary consent
• willing to undergo tumor biopsy
• negative hepatitis infection
Locations
United States
California
Children's Hospital of Los Angeles
Los Angeles
Massachusetts
Boston Children's Hospital / Dana Farber Cancer Institute
Boston
Maryland
National Cancer Institute
Bethesda
Michigan
University of Michigan
Ann Arbor
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
University of Pennsylvania
Philadelphia
Time Frame
Start Date: 2021-01-05
Completion Date: 2025-06-30
Participants
Target number of participants: 48
Treatments
Experimental: Trabectedin and Irinotecan
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.
Related Therapeutic Areas
Sponsors
Leads: Sarcoma Alliance for Research through Collaboration
Collaborators: Janssen Scientific Affairs, LLC, National Institutes of Health (NIH), National Cancer Institute (NCI)