Ongoing Clinical Trials for Metastatic Leiomyosarcoma
This article provides detailed information about 4 ongoing clinical trials investigating new treatment approaches for metastatic leiomyosarcoma, a rare cancer that originates in smooth muscle tissue and has spread to other parts of the body. These studies are testing various drug combinations including trabectedin, gemcitabine, lurbinectedin, doxorubicin, and experimental therapies across multiple European countries.
Clinical trial locations
- Austria
- Belgium
- France
- Germany
- Italy
- Netherlands
- Poland
- Portugal
- Spain
Study Comparing Trabectedin and Gemcitabine for Patients with Advanced or Metastatic Leiomyosarcoma After Chemotherapy
This trial, conducted in Italy, is comparing two different treatment approaches for patients with advanced or metastatic leiomyosarcoma who have already received chemotherapy based on anthracycline drugs. The study aims to evaluate which treatment works better in controlling the disease.
Main inclusion criteria: Participants must have confirmed leiomyosarcoma that cannot be removed by surgery or has spread to other parts of the body. They must have previously received anthracycline-based chemotherapy for advanced disease. Patients need to have measurable disease and evidence that their cancer has progressed within the past 6 months. They must be at least 18 years old with adequate blood, liver, kidney, and heart function. Women of childbearing age must have a negative pregnancy test, and both men and women must use effective birth control during the study.
Main exclusion criteria: The study excludes patients who have not previously received anthracycline-based chemotherapy, those with a different type of cancer other than leiomyosarcoma, and individuals who belong to vulnerable populations requiring special protection.
Study focus: The trial is evaluating how well trabectedin and gemcitabine work in controlling cancer growth in patients who have already undergone chemotherapy. The main measure of success is the growth modulation index, which compares how long it takes for the disease to progress with the current treatment versus previous treatments. A score greater than 1.33 is considered positive. The study also looks at overall survival, progression-free survival, and the safety of both treatments.
Investigational drugs: Trabectedin is a chemotherapy medication that interferes with the DNA in cancer cells, preventing them from growing and spreading. Gemcitabine is another chemotherapy drug that blocks cancer cells from making DNA, which is necessary for their growth and division. Both medications are given through intravenous infusion.
Study of Lurbinectedin and Doxorubicin for First-line Treatment in Patients with Metastatic Leiomyosarcoma
This international study, taking place across nine European countries (Germany, Italy, France, Austria, Netherlands, Spain, Portugal, Poland, and Belgium), is investigating whether adding a new drug called lurbinectedin to standard doxorubicin treatment can improve outcomes for patients with metastatic leiomyosarcoma as their first treatment.
Main inclusion criteria: Patients must have confirmed metastatic leiomyosarcoma that cannot be cured by surgery. They must not have received any previous treatment for metastatic disease and must not have been treated with anthracycline drugs before. The cancer must be measurable on imaging scans. Patients need to be at least 18 years old with adequate blood, kidney, liver, and heart function. They must have an ECOG performance status of 0 or 1, meaning they are either fully active or have some symptoms but can still carry out light work. Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control during the study and for seven months afterward.
Main exclusion criteria: The study does not accept patients who have a different type of cancer, have already received treatment for their metastatic disease, are pregnant or breastfeeding, are participating in another clinical trial, have serious health conditions that might interfere with treatment, or have allergies to the study medications.
Study focus: The trial aims to determine whether the combination of lurbinectedin and doxorubicin can help patients live longer without their cancer getting worse, compared to receiving doxorubicin alone. Participants are randomly assigned to receive either the combination treatment or doxorubicin alone. The study monitors how the cancer responds, safety of the treatments, and quality of life throughout the trial period.
Investigational drugs: Lurbinectedin is being tested in combination with doxorubicin to see if it can improve treatment outcomes. It works by binding to DNA in cancer cells and disrupting their ability to grow. Doxorubicin is an established chemotherapy drug that works by interfering with DNA and generating substances that lead to cancer cell death. Both medications are given through intravenous infusion.
Study of Trabectedin alone versus Trabectedin with tTF-NGR combination therapy in adults with metastatic or refractory soft tissue sarcoma who failed first-line treatment
This German study is examining whether adding an experimental drug called tTF-NGR to trabectedin chemotherapy can help keep soft tissue sarcoma (including leiomyosarcoma) under control for longer in patients whose previous treatment did not work.
Main inclusion criteria: Participants must be between 18 and 75 years old with advanced or metastatic soft-tissue sarcoma that did not respond to previous treatment with anthracycline medications, or who cannot take anthracycline due to medical reasons. The cancer must be confirmed as high-grade (grade 2-3) and include types such as leiomyosarcoma, liposarcoma, fibrosarcoma, or other specified sarcomas. Tumors must test positive for a protein marker called CD13. Patients need at least one measurable tumor, a life expectancy of at least 3 months, and an ECOG Performance Status of 2 or less. Women who can become pregnant must have a negative pregnancy test and use effective birth control during the study and for 3 months after, while men must use birth control for 5 months after treatment.
Main exclusion criteria: The study excludes individuals younger than 18 or older than 75, those without confirmed soft-tissue sarcoma, patients who haven’t received previous anthracycline therapy, those with negative CD13 test results, pregnant or breastfeeding women, patients with severe heart, liver, or kidney problems, active uncontrolled infections, other active cancers requiring treatment, known allergies to study medications, and those unable to provide informed consent.
Study focus: The trial compares treatment with trabectedin alone to trabectedin combined with tTF-NGR. The experimental drug tTF-NGR is designed to target blood vessels in tumors and help trap the chemotherapy medication inside the tumor, potentially making treatment more effective. Participants receive treatment for up to 360 days, with regular monitoring through imaging tests and medical examinations to track how the cancer responds.
Investigational drugs: Trabectedin is a chemotherapy medication that binds to DNA and interferes with cell division and DNA repair in cancer cells. tTF-NGR is an experimental protein designed to concentrate trabectedin inside tumors by targeting tumor blood vessels. Both medications are given through intravenous infusion.
Study on Berzosertib and Gemcitabine for Adults with Advanced or Metastatic Soft-Tissue Leiomyosarcomas
This French study is investigating whether adding an experimental drug called berzosertib to gemcitabine chemotherapy can improve outcomes for patients with advanced or metastatic leiomyosarcoma.
Main inclusion criteria: Patients must be adults with advanced or inoperable soft-tissue leiomyosarcoma, with diagnosis confirmed by a network of experts. At least three weeks must have passed since their last cancer treatment. They must have good blood, kidney, liver, and metabolic function with specific levels of blood cells, liver enzymes, and adequate kidney function. Patients must be 18 years or older with a good general health status and life expectancy of more than 3 months. They can have received no more than three previous treatments for advanced disease and must have measurable disease on scans. Women who can have children must have a negative pregnancy test, and both men and women must use effective birth control during the study and for a period afterward. Patients must agree to provide tumor samples and have health insurance as required by French law.
Main exclusion criteria: The study does not accept patients with a different type of cancer, those who have had recent cancer treatment that might interfere with the study, individuals with serious health problems that could make participation unsafe, pregnant or breastfeeding women, those unable to follow study procedures, patients with allergies to study medications, recent participants in other clinical trials, patients with certain infections, those who have had major surgery recently, or individuals with a history of certain heart problems.
Study focus: The trial evaluates how well berzosertib works in combination with gemcitabine compared to gemcitabine alone. Participants are randomly assigned to receive either the combination treatment or gemcitabine by itself. The study monitors cancer response, specifically looking at whether tumors shrink, remain stable, or grow, while also assessing safety and side effects. The goal is to determine whether the combination can improve progression-free survival.
Investigational drugs: Berzosertib is an experimental medication that targets a protein called ATR, which is involved in DNA repair in cancer cells. By inhibiting this protein, berzosertib may help stop cancer cell growth. Gemcitabine is a chemotherapy drug that interferes with the DNA of cancer cells, preventing them from growing and dividing. Both medications are administered through intravenous infusion.
Summary
Four clinical trials are currently underway in Europe investigating new treatment approaches for metastatic leiomyosarcoma. These studies reflect ongoing efforts to find more effective therapies for this rare and challenging cancer.
The trials are concentrated primarily in Western European countries, with France, Germany, and Italy hosting multiple studies. One large international trial spans nine countries across Europe, demonstrating collaborative research efforts in this rare disease area.
Three of the four trials focus on combination therapies, testing whether adding newer drugs to established chemotherapy medications can improve outcomes. Trabectedin and gemcitabine appear frequently across multiple studies, both as single agents and in combination with experimental drugs. The trials target different patient populations: some focus on patients receiving their first treatment for metastatic disease, while others enroll patients whose previous treatments have not worked.
All studies use intravenous infusion to deliver medications and include regular monitoring through imaging tests and medical assessments. The trials emphasize safety alongside effectiveness, carefully tracking both cancer response and any side effects experienced by participants.
