SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients
NCT ID: NCT04067115
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
37 participants
INTERVENTIONAL
2021-01-05
2025-04-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
Trabectedin 1 MG [Yondelis]
Patients with Ewing sarcoma will be administered trabectedin intravenously. Cycles are 21 days.
Irinotecan
Patients with Ewing sarcoma will be administered inirotecan intravenously. Cycles are 21 days.
tumor biopsy
Tumor tissue samples will be collected collected at two timepoints. The first biopsy will be prior to treatment. If a biopsy is not possible archival tissue may be submitted. A second tumor biopsy will be taken fro consenting patients when possible after the first administration of Trabectedin to evaluate the effect on the tumor cells.
3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging
Some patients will receive PET scans with the use of 18F-FLT, a radioactive tracer, performed at the National Institute of Health.
Interventions
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Trabectedin 1 MG [Yondelis]
Patients with Ewing sarcoma will be administered trabectedin intravenously. Cycles are 21 days.
Irinotecan
Patients with Ewing sarcoma will be administered inirotecan intravenously. Cycles are 21 days.
tumor biopsy
Tumor tissue samples will be collected collected at two timepoints. The first biopsy will be prior to treatment. If a biopsy is not possible archival tissue may be submitted. A second tumor biopsy will be taken fro consenting patients when possible after the first administration of Trabectedin to evaluate the effect on the tumor cells.
3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging
Some patients will receive PET scans with the use of 18F-FLT, a radioactive tracer, performed at the National Institute of Health.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
6 Years
99 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Sarcoma Alliance for Research through Collaboration
OTHER
Responsible Party
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Principal Investigators
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Patrick Grohar, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
John Glod, MD/PhD
Role: STUDY_DIRECTOR
National Cancer Institute (NCI)
Locations
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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
Countries
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Other Identifiers
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SARC037
Identifier Type: -
Identifier Source: org_study_id