Pleomorphic leiomyosarcoma Trials in Disease

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 clinical trial investigates treatment options for patients with pleomorphic leiomyosarcoma and other types of soft tissue sarcoma whose cancer has spread to other parts of the body or did not respond to previous treatments. The study compares two approaches: using trabectedin chemotherapy alone, or combining trabectedin with an experimental drug called tTF-NGR.

What the trial investigates: The main goal is to determine whether adding tTF-NGR to standard trabectedin treatment helps keep the cancer under control for a longer time. The experimental drug tTF-NGR is designed to help trap the chemotherapy medication inside the tumor, potentially making the treatment more effective by keeping it concentrated where it is needed most.

Investigational drugs: Trabectedin is a cancer medication that interferes with cancer cell growth and division. It is administered through intravenous infusion directly into the bloodstream. tTF-NGR is an experimental therapy that targets blood vessels in tumors and works together with trabectedin to improve treatment effectiveness. Both medications are given as infusions.

Who can participate: The trial is open to adults between 18 and 75 years of age who have advanced or metastatic soft tissue sarcoma, including pleomorphic leiomyosarcoma. Participants must have previously received treatment with anthracycline medications that either did not work or cannot be taken due to medical reasons. The tumor must test positive for a specific protein marker called CD13. Patients need to have at least one measurable tumor that has not been previously treated with radiation and a life expectancy of at least 3 months. Women who can become pregnant must have a negative pregnancy test and use effective birth control during the study and for 3 months afterward. Men must use birth control methods for 5 months after the last treatment.

Who cannot participate: The trial excludes patients who are younger than 18 or older than 75 years, those who have never received anthracycline therapy, and those whose tumors test negative for CD13. Pregnant or breastfeeding women cannot participate. Patients who have previously been treated with trabectedin, those with severe heart, liver, or kidney problems, active uncontrolled infections, or other active cancers requiring treatment are also excluded. Additionally, patients with known allergic reactions to the study medications or those participating in another clinical trial within the past 30 days cannot join this study.

What to expect during the trial: Participants will be randomly assigned to receive either trabectedin alone or trabectedin combined with tTF-NGR. Treatment is given through intravenous infusion and continues until the disease progresses or other stopping criteria are met, for up to 360 days. Throughout the study, regular imaging tests will track how the tumor responds to treatment, and overall health status will be monitored. Women of childbearing potential will need monthly pregnancy tests. After treatment completion, follow-up continues with ongoing health monitoring, and the study is expected to continue until March 2029.

Summary

Currently, there is one active clinical trial available for patients with pleomorphic leiomyosarcoma who have already undergone initial treatment. This trial is being conducted in Germany and focuses on improving outcomes for patients with advanced or metastatic disease by investigating whether adding an experimental drug to standard chemotherapy can help control cancer progression more effectively. The study specifically targets tumors that express the CD13 protein marker and is designed for patients who have previously been treated with anthracycline-based chemotherapy. The trial represents an opportunity for eligible patients to access a potentially enhanced treatment approach while contributing to research that may benefit future patients with this rare form of cancer.