RecruitingRare disease

Study on Trabectedin for Adults and Young Adults with Advanced Mesenchymal Chondrosarcoma

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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 focused on studying a rare type of cancer called mesenchymal chondrosarcoma, which can occur in both bones and soft tissues. The study is specifically looking at cases that are positive for a genetic marker known as HEY1-NCOA2. The treatment being tested in this study is a medication called trabectedin, which is also known by the code name Ecteinascidin 743. Trabectedin is given as a solution through an intravenous infusion, meaning it is administered directly into the bloodstream through a vein.

The purpose of the study is to explore how effective trabectedin is in treating patients who have already received other types of chemotherapy, specifically those that include a group of drugs called anthracyclines. The study will involve patients who are 16 years or older and have advanced or spreading forms of mesenchymal chondrosarcoma. Participants will receive trabectedin and their response to the treatment will be monitored over time. The study aims to understand how well the tumors respond to the treatment and to gather information on the overall survival and progression-free survival of the patients.

Throughout the study, researchers will also look at the safety of trabectedin and explore the genetic and molecular characteristics of tumors that respond to the treatment compared to those that do not. This includes analyzing patterns in the tumor's genetic material and evaluating the potential of using a technique called liquid biopsy, which involves testing blood samples to detect the presence of the HEY1-NCOA2 fusion, to predict how well a patient might respond to the treatment. The study is expected to continue until 2027, providing valuable insights into the treatment of this rare cancer type.

The research process

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

Step 1
Joining the study
Upon joining the study, the patient must meet specific criteria, including being at least 16 years old and having a confirmed diagnosis of mesenchymal chondrosarcoma with the presence of HEY1-NCOA2 fusion.
The patient must have been pre-treated with at least one prior chemotherapy treatment containing anthracyclines for the advanced phase of the disease.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the patient's health status, including cardiac function and overall health condition.
A negative pregnancy test is required for female patients of childbearing potential within 7 days before starting each cycle of chemotherapy.
Step 3
Treatment administration
The patient receives trabectedin through an intravenous infusion. The specific dosage and frequency are determined based on the patient's condition and response to previous treatments.
The treatment is administered in cycles, with the duration and number of cycles depending on the patient's response and overall health.
Step 4
Monitoring and evaluation
Throughout the study, the patient's response to the treatment is monitored using criteria such as the RECIST v1.1 to assess tumor response.
Regular evaluations are conducted to monitor the patient's health, including blood tests and imaging studies to track the progression of the disease.
Step 5
End of treatment
The study aims to assess the overall tumor response rate and other outcomes such as overall survival and progression-free survival.
The study is estimated to conclude by September 14, 2027, with ongoing assessments of the patient's condition and response to treatment.

Who can join the trial?

13 criteria

Must be at least 16 years old.
Female patients who can have children must have a negative pregnancy test within 7 days before starting each cycle of chemotherapy. Women who have stopped having periods for at least 12 months are considered unable to have children. Both male and female patients who can have children must agree to use effective birth control during the study and for 3 months after the study for women and 5 months for men.
Heart function must be at least 50% as measured by an echocardiogram, which is a test that uses sound waves to create pictures of the heart.
No history of blood clots in the arteries or veins in the past 12 months.
The patient or their legal representative must be able to read and understand the informed consent form and be willing to sign it before any study-specific procedures.
Must have a confirmed diagnosis of a specific type of cancer called MCS, with a documented presence of a specific genetic fusion called **HEY1-NCOA2**. A sample of the tumor is required for review.
Must have locally advanced disease, meaning surgery is not possible or not accepted by the patient, or the disease is metastatic, meaning it has spread to other parts of the body.
Must have measurable or evaluable disease according to specific criteria called **RECIST v1.1**.
Must show evidence of disease progression according to **RECIST v1.1** within 6 months before entering the study.
Must have been treated with at least one prior chemotherapy treatment containing anthracyclines, which are a type of cancer drug, for the advanced phase of the disease, with a maximum of 3 lines of treatment.
Must have an **ECOG Performance Status** of 2 or less, which is a scale used to assess how a patient's disease is affecting their daily living abilities.
Must have adequate bone marrow function, which means the bone marrow is working well to produce blood cells. Blood transfusions to reach the required hemoglobin level are not allowed.
Must have adequate organ function, meaning the organs are working well enough to participate in the study.

Who cannot join the trial?

6 criteria

Patients who have not been diagnosed with advanced rearranged mesenchymal chondrosarcoma cannot participate. This is a specific type of cancer.
Patients who are younger than 16 years old are not eligible to join the study.
Patients who have not been treated with anthracycline-based chemotherapy before cannot take part. This is a type of cancer treatment.
Patients who do not have a HEY1-NCOA2 positive result are excluded. This refers to a specific genetic marker found in some cancer cells.
Patients who have not received one, two, or three lines of medical treatment for their condition are not eligible. This means they must have tried one to three different treatment plans before.
Patients who do not have progressive disease according to RECIST v1.1 are excluded. This means their cancer must be getting worse based on specific medical criteria.

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Verified sites

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Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy
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Azienda USL Toscana Centro
Prato, Italy
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Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy

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Investigated drugs

Trabectedin is a medication being studied for its effectiveness in treating a specific type of cancer called mesenchymal chondrosarcoma (MCS) in adults and young adults. This cancer is characterized by a genetic marker known as HEY1-NCOA2. Trabectedin is used in patients who have already received other treatments, specifically those who have been treated with anthracycline-based chemotherapy. The goal of using trabectedin in this study is to see how well it can reduce the size of the tumors in these patients.

Trabectedin

What is already known about the treatment

Trabectedin – Trabectedin is administered intravenously, typically through an infusion into a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced mesenchymal chondrosarcoma, particularly in patients who have already undergone other chemotherapy treatments. The main therapeutic indication for trabectedin is its use in certain types of soft tissue sarcomas, including mesenchymal chondrosarcoma. At the molecular level, trabectedin works by binding to the minor groove of DNA, disrupting the cell cycle and leading to cell death, particularly in cancer cells. It is classified pharmacologically as an antineoplastic agent, specifically a DNA-binding agent.

Investigated diseases

Advanced rearranged mesenchymal chondrosarcoma – This is a rare type of cancer that originates in the cartilage-producing cells and is characterized by a specific genetic rearrangement involving the HEY1-NCOA2 genes. It typically presents as a rapidly growing tumor that can occur in bones or soft tissues. The disease often progresses to an advanced stage, where it may spread to other parts of the body, such as the lungs. Patients with this condition have usually undergone previous treatments, including chemotherapy, but the cancer continues to progress. The focus of ongoing studies is to understand the tumor's response to new treatments and to explore the genetic and molecular characteristics of the disease.