Ongoing Clinical Trials for Undifferentiated Sarcoma
There is currently 1 ongoing clinical trial for patients with undifferentiated sarcoma. This trial is investigating a combination treatment approach for patients whose cancer has spread or has not responded to previous treatments. The study is being conducted in Germany and compares standard chemotherapy alone with a combination of standard chemotherapy plus an experimental drug designed to concentrate the medication inside tumors.
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 undifferentiated sarcoma, 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 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 (grade 2-3), including undifferentiated sarcoma and several other specific types such as liposarcoma, fibrosarcoma, leiomyosarcoma, rhabdomyosarcoma, angiosarcoma, and synovial sarcoma
- Cancer that is advanced or has spread to other parts of the body and either did not respond to previous treatment with anthracycline medications or the patient cannot take anthracycline medications for medical reasons
- At least one measurable tumor that has not been previously treated with radiation
- Positive test result for CD13, a specific protein marker found on cells, with a score of 1 or higher
- Life expectancy of at least 3 months
- Ability to carry out daily activities with an ECOG Performance Status of 2 or less
- Women of childbearing potential 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
- No confirmed diagnosis of soft-tissue sarcoma
- No previous treatment with anthracycline therapy
- Negative test result for CD13
- Current pregnancy 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
- Participation in another clinical trial within the past 30 days
Focus and goal of the trial:
The study aims to determine whether adding an experimental drug called tTF-NGR to standard trabectedin treatment helps keep the cancer under control for a longer time compared to trabectedin alone. Participants are randomly assigned to one of two treatment groups. The first group receives only trabectedin, a chemotherapy medication that interferes with cancer cell growth and division. The second group receives both trabectedin and tTF-NGR, an experimental protein that targets blood vessels in tumors and is designed to help trap the chemotherapy medication inside the tumor tissue.
Both medications are given through intravenous infusion directly into the bloodstream. Treatment can continue for up to 360 days, depending on how the cancer responds and whether any significant side effects occur. Throughout the study, participants undergo regular medical examinations and imaging tests to monitor how their cancer responds to treatment. The study is particularly focused on patients whose tumors test positive for CD13, a specific characteristic that is determined through laboratory testing.
Investigational drugs:
Trabectedin is a cancer medication used to treat soft tissue sarcoma. It works by interfering with cancer cell growth and division and is typically used when other treatments, particularly those containing anthracyclines, have not worked effectively.
tTF-NGR is an experimental therapy designed to work together with trabectedin. It is a protein that targets blood vessels in tumors and is intended to help trap the cancer medication inside the tumor. This combination approach aims to make the cancer treatment more effective by keeping the medication concentrated where it is needed most.
Summary
Currently, there is one ongoing clinical trial available for patients with undifferentiated sarcoma. This trial is being conducted in Germany and focuses on patients whose cancer has spread or has not responded to initial treatment. The study investigates whether combining trabectedin with the experimental drug tTF-NGR provides better cancer control than trabectedin alone. A notable feature of this trial is that it requires participants to test positive for CD13, a specific protein marker, which suggests the treatment approach may be particularly effective for patients whose tumors express this characteristic. The study represents an important research effort to improve treatment options for patients with advanced soft tissue sarcoma, including undifferentiated sarcoma, who have limited therapeutic alternatives after standard treatments have failed.
