Status:
COMPLETED
SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients
Lead Sponsor:
Sarcoma Alliance for Research through Collaboration
Collaborating Sponsors:
Janssen Scientific Affairs, LLC
National Institutes of Health (NIH)
Conditions:
Ewing Sarcoma
Eligibility:
All Genders
6-99 years
Phase:
PHASE1
PHASE2
Brief 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 Emiss...
Detailed Description
Trabectedin and Irinotecan may inhibit the activity of this Ewing sarcoma mutation. Trabectedin may suppress the proliferation of the gene involved in DNA damage response. It blocks EWS-FLI1 by inacti...
Eligibility Criteria
Inclusion
- 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
Exclusion
- prior therapy with trabectedin or lurbinectedin
- known history of hypersensitivity to irinotecan or topotecan or their excipients.
- known brain metastases
- known bleeding diathesis
- pregnant or breastfeeding
- currently receiving other investigational drugs or anticancer agents
- clinically significant unrelated illness or uncontrolled infection
- unable to comply with the safety monitoring requirements
Key Trial Info
Start Date :
January 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2025
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04067115
Start Date
January 5 2021
End Date
April 24 2025
Last Update
December 17 2025
Active Locations (6)
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1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
National Cancer Institute
Bethesda, Maryland, United States, 20892
3
Boston Children's Hospital / Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
University of Michigan
Ann Arbor, Michigan, United States, 48106