In short
Currently, there is 1 ongoing clinical trial for patients with fibrosarcoma. This trial is being conducted in Germany and focuses on testing a combination treatment approach for patients whose cancer has spread or has not responded to previous treatments. The study compares standard chemotherapy alone to a combination of standard chemotherapy with an experimental drug designed to concentrate the medication inside the tumor.
Clinical trial locations
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 is designed for patients with soft tissue sarcoma, including fibrosarcoma, whose cancer has either spread to other parts of the body or has not responded to previous treatments. The study compares two different treatment approaches to determine which one is more effective at keeping the cancer under control.
What treatments are being tested?
The trial tests trabectedin, a chemotherapy medication that works by interfering with cancer cell growth and division. This drug is already used to treat soft tissue sarcoma when other treatments have not worked. The experimental part of the study involves adding tTF-NGR, a new drug designed to help trap trabectedin inside the tumor, potentially making the chemotherapy more effective. Both medications are given through intravenous infusion directly into the bloodstream.
Who can participate?
The trial is open to adults aged 18 to 75 years with confirmed high-grade fibrosarcoma or other types of soft tissue sarcoma. Eligible participants must have cancer that has spread or has not responded to previous treatment with anthracycline medications, or they must have medical reasons preventing them from taking anthracyclines. Importantly, the tumor must test positive for a specific protein marker called CD13. Participants must have at least one measurable tumor that has not been previously treated with radiation and must have a life expectancy of at least 3 months. They should be able to carry out daily activities and attend scheduled visits throughout the study.
Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control during the study and for 3 months afterward. Men must use birth control methods for 5 months after their last treatment.
Who cannot participate?
The trial excludes patients who are younger than 18 or older than 75 years. Those who have not previously been treated with anthracycline therapy or who test negative for the CD13 protein marker cannot participate. The study is not suitable for women who are pregnant or breastfeeding. Patients with severe heart, liver, or kidney problems are excluded, as are those with active uncontrolled infections or other active cancers requiring treatment. Anyone who has previously been treated with trabectedin, has known allergic reactions to the study medications, or has participated in another clinical trial within the past 30 days cannot join this study.
What is the main goal of the trial?
The primary focus of this study is to determine whether combining tTF-NGR with standard trabectedin treatment helps keep the cancer under control for a longer time compared to using trabectedin alone. The trial will involve regular medical examinations and imaging tests to monitor how the cancer responds to treatment. Some patients will receive only trabectedin, while others will receive both trabectedin and tTF-NGR. Treatment can continue for up to 360 days, depending on how well the cancer responds and how the patient tolerates the medications.
What happens during the trial?
The study follows a structured process. First, doctors confirm that the patient has soft tissue sarcoma that meets the study criteria and test the tumor for CD13 positivity. Imaging tests measure the tumor size. Participants are then randomly assigned to receive either trabectedin alone or trabectedin combined with tTF-NGR. Throughout treatment, regular imaging tests track the tumor's response, and overall health is closely monitored. Women of childbearing potential require monthly pregnancy tests. After treatment ends, participants must continue using effective contraception for several months and will have their health status monitored according to the study schedule. The study is expected to continue until March 2029.
Summary
Currently, only one clinical trial is available for patients with fibrosarcoma. This trial is being conducted in Germany and focuses on improving treatment outcomes for patients whose cancer has spread or has not responded to initial therapies. The study is testing whether adding an experimental drug called tTF-NGR to standard trabectedin chemotherapy can help control the cancer more effectively. A key requirement for participation is that the tumor must test positive for a specific protein marker called CD13. This trial represents an important opportunity for eligible patients to access a potentially improved treatment approach while contributing to medical knowledge about fibrosarcoma treatment.
