Promising new combo tackles tough bone cancer
NCT ID NCT04067115
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two drugs, trabectedin and irinotecan, in 37 people with a type of bone cancer called Ewing sarcoma that had come back or not responded to other treatments. The goal was to find a safe dose and see if the combination could shrink tumors. Participants also received a special PET scan to help measure the treatment's effect.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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37 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Apr 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Boston Children's Hospital / Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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National Cancer Institute
Bethesda, Maryland, 20892, United States
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University of Michigan
Ann Arbor, Michigan, 48106, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19105, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A simple blood test may reveal hidden infertility risk in young cancer survivors
- Can engineered immune cells tackle childhood sarcoma?
- A simple blood test may reveal how ewing sarcoma responds to therapy
- Targeted radiation zaps childhood brain tumors in early trial