Angiosarcoma recurrent 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 trial is designed for patients with soft tissue sarcoma, including angiosarcoma, whose cancer has either spread to other parts of the body or has not responded to previous treatments. The study compares two treatment approaches to determine which one works better at controlling the cancer.

Main inclusion criteria:

• Adults between 18 and 75 years of age
• Confirmed diagnosis of high-grade soft tissue sarcoma, including angiosarcoma
• Cancer that has not responded to previous anthracycline treatment, or inability to receive anthracyclines due to medical reasons
• Tumor must test positive for CD13, a specific protein marker
• At least one measurable tumor that has not been treated with radiation
• Life expectancy of at least 3 months
• Ability to carry out daily activities with minimal assistance
• Women of childbearing age 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

Main exclusion criteria:

• Age below 18 or above 75 years
• Absence of confirmed soft tissue sarcoma diagnosis
• No previous treatment with anthracycline therapy
• Tumor tests negative for CD13 protein marker
• Currently pregnant or breastfeeding
• Previous treatment with trabectedin
• Severe heart, liver, or kidney problems
• Active uncontrolled infections
• Other active cancers requiring treatment
• Known allergic reactions to the study medications

Focus and goals:

The trial aims to determine whether adding an experimental drug called tTF-NGR to standard trabectedin treatment helps control cancer growth for a longer period compared to using trabectedin alone. Participants are randomly assigned to one of two groups: one receiving only trabectedin, and another receiving both trabectedin and tTF-NGR. Both medications are given through an intravenous infusion directly into the bloodstream.

The study specifically focuses on patients whose tumors show a characteristic called CD13 positivity, which is determined through laboratory testing. Treatment continues for up to 360 days, and patients undergo regular medical examinations and imaging tests to monitor how the cancer responds. The study is expected to continue until March 2029.

Investigational drugs:

Trabectedin is a chemotherapy medication that interferes with cancer cell growth and division. It is typically used when previous treatments, particularly anthracycline-based therapies, have not been effective. The medication is delivered through intravenous infusion.

tTF-NGR is an experimental drug designed to work in combination with trabectedin. It targets blood vessels within tumors and is intended to help concentrate the chemotherapy medication inside the tumor tissue. This combination approach aims to make the cancer treatment more effective by keeping the medication where it is needed most.

Summary

Currently, there is one clinical trial available for patients with recurrent angiosarcoma. This trial is being conducted in Germany and offers an opportunity for patients whose cancer has not responded to standard first-line treatments. The study investigates whether combining an experimental drug, tTF-NGR, with the established chemotherapy medication trabectedin provides better cancer control than trabectedin alone.

The trial is specifically designed for patients whose tumors test positive for the CD13 protein marker and who have previously received anthracycline therapy or cannot receive such treatment due to medical reasons. Participants must be between 18 and 75 years old and have a life expectancy of at least 3 months. The study emphasizes close monitoring through regular examinations and imaging tests to track treatment response.

For patients with recurrent angiosarcoma who meet the eligibility criteria, this trial represents an opportunity to access a novel treatment combination that may offer improved outcomes compared to standard therapy alone.