Ongoing Clinical Trials for Lymphangiosarcoma
Currently, there is 1 ongoing clinical trial for lymphangiosarcoma, a rare type of cancer that develops in the soft tissues. This trial is investigating combination therapies for patients whose cancer has spread or has not responded to initial treatments. The study is being conducted in Germany and focuses on comparing standard chemotherapy alone versus a combination approach that includes an experimental targeted drug.
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 examines treatment options for soft tissue sarcoma, including lymphangiosarcoma, a rare cancer affecting the soft tissues of the body. The study is designed for patients whose cancer has spread to other parts of the body or who have not responded well to initial treatments.
Main focus: The trial compares two treatment approaches. The first approach uses trabectedin alone, while the second combines trabectedin with tTF-NGR, an experimental drug. The goal is to determine whether adding tTF-NGR helps control the cancer for a longer period. Both medications are given through intravenous infusion, with treatment continuing for up to 360 days. The experimental drug tTF-NGR is designed to help concentrate the chemotherapy medication inside the tumor, potentially making the treatment more effective.
Who can participate: The trial is open to adults between 18 and 75 years of age who have advanced or metastatic soft tissue sarcoma that did not respond to previous treatment with anthracycline medications, or who cannot take anthracycline medications for medical reasons. Participants must have confirmed high-grade sarcoma of specific types, including angiosarcoma (which includes lymphangiosarcoma), liposarcoma, fibrosarcoma, leiomyosarcoma, rhabdomyosarcoma, synovial sarcoma, or undifferentiated sarcoma. An important requirement is that the tumor must test positive for CD13, a specific protein marker, with a score of 1 or higher. Participants must have at least one measurable tumor that has not been treated with radiation, a life expectancy of at least 3 months, and be able to carry out daily activities. 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 the last treatment.
Who cannot participate: The trial excludes individuals below 18 or above 75 years of age, those without confirmed soft tissue sarcoma, and those who have not previously received anthracycline therapy. Patients whose tumors test negative for CD13 cannot participate. The study also excludes women who are currently pregnant or breastfeeding. Other exclusion criteria include previous treatment with trabectedin, severe heart conditions, severe liver or kidney problems, active uncontrolled infections, other active cancers requiring treatment, and known allergic reactions to the study medications. Patients who cannot provide informed consent or who have participated in another clinical trial within the past 30 days are also excluded.
Investigational drugs: The trial uses trabectedin, a cancer medication that interferes with cancer cell growth and division, typically used when other treatments have not been effective. The experimental component is tTF-NGR, a protein designed to target blood vessels in tumors and help trap trabectedin inside the tumor, potentially making the treatment more effective by keeping the medication concentrated where it is needed most.
Participants will be randomly assigned to receive either trabectedin alone or trabectedin combined with tTF-NGR. Throughout the study, regular medical examinations and imaging tests will monitor how the cancer responds to treatment. The study is expected to continue until March 2029.
Summary
There is currently one clinical trial available for patients with lymphangiosarcoma and related soft tissue sarcomas. This trial, conducted in Germany, represents an important research effort for patients whose cancer has not responded to standard first-line treatments. The study focuses on determining whether adding an experimental targeted therapy to standard chemotherapy can improve outcomes for patients with advanced disease.
A notable aspect of this trial is its requirement for CD13 positivity, meaning that not all patients with soft tissue sarcoma will qualify. Patients interested in participating should discuss with their healthcare provider whether testing for CD13 is appropriate and whether they meet the other eligibility criteria. The trial’s age restriction (18-75 years) and the requirement for previous anthracycline treatment also limit eligibility to a specific patient population.
For patients with metastatic or refractory lymphangiosarcoma who have exhausted standard treatment options and meet the eligibility criteria, this trial may offer access to a novel combination therapy approach that aims to improve how chemotherapy is delivered to tumors.
