Spots Global Cancer Trial Database for SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients
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Trial Identification
Brief Title: SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients
Official Title: 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
Study ID: NCT04067115
Conditions
Study Description
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 Emission Tomography (PET) scan to help evaluate the effect of treatment. Phase I was completed on 11/16/2022. Phase II is actively recruiting.
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 inactivating the fusion protein and silences the target genes. Irinotecan also suppresses the genes regulating the tumor cells, generating DNA damage. Together, these drugs work in combination to suppress the gene regulating the tumor cells. This combination may suppress the activity of the tumor regulating genes, disrupting the activity of the genes. The infusion of 18F-FLT in combination with a Positron Emission Tomography (PET) scan will demonstrate whether the target cells have been suppressed.
Keywords
Eligibility
Minimum Age: 6 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of Los Angeles, Los Angeles, California, United States
National Cancer Institute, Bethesda, Maryland, United States
Boston Children's Hospital / Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Contact Details
Name: Patrick Grohar, MD/PhD
Affiliation: Children's Hospital of Philadelphia
Role: PRINCIPAL_INVESTIGATOR
Name: John Glod, MD/PhD
Affiliation: National Cancer Institute (NCI)
Role: STUDY_DIRECTOR
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