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Study of lurbinectedin and irinotecan in adults and young adults with advanced desmoplastic small round cell tumor

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying the effectiveness of combining two medications - lurbinectedin and irinotecan - in treating desmoplastic small round cell tumor (DSRCT), a rare type of cancer. The study is designed for adults and young adults who have advanced forms of this disease that have continued to progress after previous treatments.

The study will use lurbinectedin, which is given as a powder that is made into a solution for infusion, and irinotecan, which is given as a solution directly into the vein. These medications will be given to patients whose cancer has grown or spread after receiving between one to three previous treatments that included drugs called anthracyclines.

The main goal is to see how well tumors respond to this combination of medications. The researchers will also track how long patients survive, how long they live without their disease getting worse, and monitor any side effects. Patients will also complete questionnaires about their quality of life and pain levels during the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical assessment

    A doctor will confirm your diagnosis of desmoplastic small round cell tumor (DSRCT) through laboratory tests

    Your current health status will be evaluated, including blood tests, heart function test (showing heart efficiency of at least 50%), and tumor measurements

    Previous treatments and their effects will be reviewed

  2. Step 2

    Treatment preparation

    Blood tests will be performed to check your bone marrow, kidney, and liver function

    For female patients: a pregnancy test must be completed within 7 days before starting treatment

    You must recover from any side effects of previous treatments (except mild tiredness or hair loss)

  3. Step 3

    Treatment administration

    You will receive two medications through an intravenous infusion (directly into your vein):

    Lurbinectedin - given as a powder that will be mixed into a solution

    Irinotecan - given as a prepared solution

    The treatment will be administered in cycles at the hospital

  4. Step 4

    Monitoring during treatment

    Regular assessment of your tumor response using imaging scans

    Blood tests to monitor your health status

    Evaluation of any side effects using standardized criteria

    Quality of life assessments using questionnaires

    Pain level monitoring

  5. Step 5

    Follow-up period

    After completing treatment, you will need to use effective birth control methods:

    Female patients: for at least 7 months after the last dose

    Male patients: for at least 4 months after the last dose

    Your health status will continue to be monitored after treatment ends

Who can join the trial?

17 criteria

  • Must be at least 15 years old
  • Must have a confirmed diagnosis of DSRCT with EWSR1-WT1 translocation (a specific genetic change in the tumor)
  • Must have recovered from side effects of previous treatments to mild level or baseline (except for hair loss, skin problems, or mild tiredness)
  • No blood clots in arteries or veins in the past 12 months
  • Must have advanced cancer that cannot be fully removed by surgery or has spread to other parts of the body
  • Must have measurable disease that can be tracked with scans
  • Must have received 1-3 previous chemotherapy treatments, including at least one with anthracycline (a type of chemotherapy drug)
  • Must be able to perform daily activities with some limitations (ECOG Performance Status of 2 or better)
  • Must have adequate blood test results showing:
    • Sufficient blood cell counts
    • Proper liver function
    • Adequate kidney function
    • Normal blood clotting
    • Must have good heart function (ejection fraction of 50% or higher)
    • Women who can become pregnant must have a negative pregnancy test within 7 days before starting treatment
    • All participants who can have children must use effective birth control during the study and:
      • Women: for 7 months after last treatment
      • Men: for 4 months after last treatment
      • Must be able to understand and sign the informed consent form

Who cannot join the trial?

12 criteria

  • Age below 15 years old
  • No confirmed diagnosis of EWSR1-WT1 translocated DSRCT (a specific genetic mutation that must be present in the tumor)
  • Have not received prior treatment with anthracyclines (a type of chemotherapy medication)
  • Have received more than 4 previous lines of treatment
  • Have received less than 1 previous line of treatment
  • No evidence of disease progression according to RECIST criteria (standardized way to measure if cancer has grown)
  • Unable to provide informed consent
  • Pregnancy or breastfeeding
  • Active or uncontrolled infections
  • Other serious medical conditions that could interfere with study participation
  • Currently participating in another clinical trial
  • Known allergies or hypersensitivity to the study medications (lurbinectedin or irinotecan)
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Investigated drugs

  • Lurbinectedin

    A medication used in cancer treatment that works by interfering with DNA processes in cancer cells. It's being studied for treating desmoplastic small round cell tumor (DSRCT), a rare and aggressive type of cancer.

  • Irinotecan

    A chemotherapy medication that works by stopping cancer cells from dividing and growing. It belongs to a class of drugs called topoisomerase inhibitors and is commonly used to treat various types of cancer. In this study, it's being tested in combination with lurbinectedin for treating DSRCT.

What is already known about the treatment

  • Lurbinectedin

    A synthetic alkaloid administered intravenously that works by binding to DNA and disrupting cancer cell division. Currently used in clinical trials for treating desmoplastic small round cell tumor (DSRCT), this medication belongs to the antineoplastic agents class. It functions by targeting transcription and DNA repair mechanisms in cancer cells, making it particularly effective against aggressive tumors.

  • Irinotecan

    An intravenously administered chemotherapy drug that belongs to the topoisomerase I inhibitor class of medications. It works by interfering with cancer cell DNA replication, preventing tumor cells from dividing and multiplying. This medication is commonly used in various cancer treatments and is being studied in combination with lurbinectedin for treating advanced desmoplastic small round cell tumor, particularly in cases where previous treatments have not been successful.

Investigated diseases

Desmoplastic Small Round Cell Tumor – A rare and aggressive type of soft tissue cancer that typically develops in the abdomen or pelvis. The disease most commonly occurs in young males, characterized by the growth of small, round cancer cells surrounded by scar-like fibrous tissue. It begins in the cells that line the inside of the abdomen and can spread to other parts of the body. The condition is associated with a specific genetic change involving the EWSR1 and WT1 genes. This cancer can cause swelling in the abdomen, pain, and changes in bowel habits.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519261-21-00Protocol codeISG-TULIPSEstimated enrolment20 patientsSponsorItalian Sarcoma Group

sourced from the EU Clinical Trials Register and site verification

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