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 trial is being conducted in Germany and focuses on 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 treatment approaches: using trabectedin alone or combining it with an experimental drug called tTF-NGR.

Main inclusion criteria: Participants must be between 18 and 75 years old with confirmed high-grade soft tissue sarcoma, including angiosarcoma, that has either not responded to previous anthracycline treatment or where anthracycline medications cannot be used due to medical reasons. The tumor must test positive for a protein marker called CD13 with a score of 1 or higher. Participants 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 agree to use effective birth control during the study and for 3 months afterward. Men must use birth control for 5 months after the last treatment.

Main exclusion criteria: The study excludes patients below 18 or above 75 years of age, those without a confirmed diagnosis of soft-tissue sarcoma, and those who have not received previous anthracycline therapy. People who test negative for CD13, are currently pregnant or breastfeeding, or have previously been treated with trabectedin are not eligible. Patients with severe heart, liver, or kidney problems, active uncontrolled infections, other active cancers requiring treatment, known allergic reactions to the study medications, or those unable to provide informed consent are also excluded.

Focus and goal: The study aims to determine if 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. Both medications are given through intravenous infusion. Participants will receive treatment for up to 360 days, with regular medical examinations and imaging tests to monitor how the cancer responds.

Investigational drugs: Trabectedin is a cancer medication that works by interfering with cancer cell growth and division. It is typically used when other treatments, particularly anthracycline-based therapies, have not worked effectively. tTF-NGR is an experimental protein that targets blood vessels in tumors and is intended to help concentrate trabectedin inside the tumor, potentially making the cancer treatment more effective.

Study on Propranolol and Pembrolizumab for Patients with Advanced Angiosarcoma and Undifferentiated Pleomorphic Sarcoma

This clinical trial is being conducted in Denmark and Norway and specifically focuses on advanced angiosarcoma and undifferentiated pleomorphic sarcoma. The study explores the effects of a combination treatment using propranolol hydrochloride and pembrolizumab.

Main inclusion criteria: Participants must be at least 18 years old with confirmed advanced or spreading angiosarcoma or undifferentiated pleomorphic sarcoma that has not responded to standard chemotherapy. They must have an ECOG Performance Status score of 2 or less, which measures their ability to perform daily activities, and disease that can be measured according to specific criteria. Blood test requirements include serum bilirubin no more than 1.5 times the normal limit, liver enzymes no more than 5 times the normal limit, serum creatinine no more than 1.5 times the normal limit, absolute neutrophil count at least 1 x 10⁹/L, and platelet count at least 75 x 10⁹/L. Participants must provide a tumor tissue sample taken within 3 months before joining the study. Women who can have children and men who are sexually active with women who can have children must agree to use effective birth control during the study and for at least 120 days after treatment.

Main exclusion criteria: The study excludes patients with cancer types other than advanced angiosarcoma and undifferentiated pleomorphic sarcoma, those not within the specified age range, and those unable to follow study procedures or attend required visits. People who are pregnant or breastfeeding, participating in another clinical trial, have had recent surgery or treatment that might affect results, have allergies to the study medications, have a history of substance abuse, or cannot provide informed consent are not eligible. Patients with other serious health conditions that might interfere with the study are also excluded.

Focus and goal: The purpose of this study is to evaluate how well the combination treatment works in controlling cancer growth over a period of three months. The primary goal is to determine the progression-free survival rate at 3 months using standard tumor measurement criteria. Throughout the study, participants will have regular clinic visits for treatment and monitoring, including various tests and assessments to track the cancer's response to treatment.

Investigational drugs: Propranolol is a beta-blocker medication commonly used to treat heart conditions, but is being investigated here for its potential effects on cancer. Researchers are interested in how propranolol might help slow down or stop the growth of these tumors. It is taken orally in tablet form. Pembrolizumab is an immunotherapy drug that helps the body's immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells. Pembrolizumab is administered intravenously as a solution for infusion.

Summary

Two clinical trials are currently recruiting patients with angiosarcoma, offering different treatment approaches depending on the specific situation. The German trial is part of a broader study for various types of soft tissue sarcoma and focuses on improving chemotherapy delivery using a novel targeting approach with tTF-NGR combined with trabectedin. This trial is particularly suitable for patients whose cancer did not respond to anthracycline-based chemotherapy and whose tumors express the CD13 marker.

The Denmark and Norway trial takes a different approach by combining an immunotherapy drug with a repurposed heart medication. This innovative combination of pembrolizumab and propranolol specifically targets advanced angiosarcoma and undifferentiated pleomorphic sarcoma that has not responded to standard chemotherapy. The trial aims to demonstrate effectiveness within a relatively short three-month evaluation period.

Both trials require participants to meet specific health criteria and have measurable disease. The geographical distribution of these trials across Northern and Central Europe provides access to experimental treatments for patients in these regions who have exhausted standard treatment options.