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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Azienda USL Toscana Centro	Prato	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hqoqgkol Vstc dekszpsc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.10.2025
Spain	Not yet recruiting	01.10.2025

Trial locations

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.

Investigated diseases:

Desmoplastic small round cell tumour

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 ID:

2024-519261-21-00

Protocol code:

ISG-TULIPS

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?