Hepatic angiosarcoma 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 is studying treatment options for patients with soft tissue sarcoma, including angiosarcoma, whose cancer has spread to other parts of the body or has not responded to previous treatments. The study compares two approaches: treatment with trabectedin alone, or trabectedin combined with an experimental drug called tTF-NGR.

Main focus and goal: The trial aims to determine whether adding tTF-NGR to standard trabectedin treatment helps control the cancer for a longer period. The experimental drug tTF-NGR is designed to help trap the chemotherapy medication inside the tumor, potentially making the treatment more effective. Both medications are given through intravenous infusion directly into the bloodstream, and treatment can continue for up to 360 days.

Who can participate: The trial is open to adults between 18 and 75 years of age who have confirmed high-grade soft tissue sarcoma, including angiosarcoma. Participants must have cancer that either did not respond to previous treatment with anthracycline medications or who cannot take these medications due to medical reasons. 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 a life expectancy of at least 3 months. Women of childbearing potential 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 the last treatment.

Who cannot participate: The trial excludes individuals who are younger than 18 or older than 75 years, those without confirmed soft tissue sarcoma diagnosis, and those who have never received anthracycline therapy. Participants must test positive for CD13, so those with negative test results are excluded. Pregnant or breastfeeding women cannot participate. People who have previously been treated with trabectedin, have severe heart, liver, or kidney problems, active uncontrolled infections, or other active cancers requiring treatment are also excluded. Those with known allergic reactions to the study medications or who have participated in another clinical trial within the past 30 days cannot join this study.

Investigational drugs: Trabectedin is a cancer medication that interferes with cancer cell growth and division. It is typically used when other treatments have not worked effectively. tTF-NGR is an experimental therapy that targets blood vessels in tumors and is intended to help trap trabectedin inside the tumor, making the cancer treatment more effective by keeping the medication concentrated where it is needed most.

Summary

There is currently one clinical trial available for patients with hepatic angiosarcoma, conducted in Germany. This trial focuses on comparing standard chemotherapy with trabectedin alone versus a combination approach using trabectedin plus the experimental drug tTF-NGR. The study specifically targets patients whose cancer has spread or has not responded to previous treatments, and whose tumors test positive for the CD13 protein marker. The trial represents an opportunity for patients who have limited treatment options after first-line therapy has failed.