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Promising new combo tackles tough bone cancer

NCT ID NCT04067115

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

37 people

The number who actually took part.

Started

Jan 2021

Finished

Apr 2025

Lead sponsor

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

6 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Boston Children's Hospital / Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • National Cancer Institute

    Bethesda, Maryland, 20892, United States

  • University of Michigan

    Ann Arbor, Michigan, 48106, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19105, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.