Ongoing Clinical Trials for Recurrent Rhabdomyosarcoma
There is currently 1 ongoing clinical trial for patients with recurrent rhabdomyosarcoma. This trial is being conducted in Germany and focuses on a combination treatment approach for patients whose cancer has spread or did not respond to previous treatments. The study compares trabectedin alone with trabectedin combined with an experimental drug called tTF-NGR.
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 recurrent rhabdomyosarcoma, whose cancer has spread to other parts of the body or did not respond to previous treatments. The study compares two treatment approaches to determine which is more effective at keeping the cancer under control.
Main inclusion criteria:
- Adults between 18 and 75 years of age
- Confirmed high-grade soft tissue sarcoma (grade 2-3), including rhabdomyosarcoma and other specific types
- Advanced or metastatic disease that either did not respond to previous anthracycline treatment or where anthracycline cannot be used for medical reasons
- Tumor must test positive for CD13, a specific protein marker, with a score of 1 or higher
- At least one measurable tumor that has not been previously treated with radiation
- Life expectancy of at least 3 months
- Ability to carry out daily activities (ECOG Performance Status of 2 or less)
- For women of childbearing age: negative pregnancy test and willingness to use effective birth control during the study and for 3 months after
- For men: willingness to use birth control methods for 5 months after the last treatment
Main exclusion criteria:
- Age below 18 or above 75 years
- No previous treatment with anthracycline chemotherapy
- Tumor tests negative for CD13
- Currently pregnant or breastfeeding
- No measurable disease present
- 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 tTF-NGR to standard trabectedin treatment helps control the cancer 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 intravenous infusion directly into the bloodstream. Treatment can continue for up to 360 days, depending on how the cancer responds and the patient’s overall health.
The experimental drug tTF-NGR is designed to help trap the chemotherapy medication inside the tumor, potentially making the treatment more effective by concentrating it where it is needed most. Throughout the study, participants undergo regular medical examinations and imaging tests to monitor how the cancer responds to treatment. The trial is expected to continue until March 2029.
Investigational drugs:
Trabectedin is a cancer medication that interferes with cancer cell growth and division. It is typically used when other treatments, particularly those containing anthracyclines, have not worked effectively. This medication is administered through intravenous infusion.
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 in the tumor tissue.
Summary
Currently, there is one ongoing clinical trial available for patients with recurrent rhabdomyosarcoma. This trial is being conducted in Germany and focuses on patients whose cancer has spread or did not respond to previous treatments. The study specifically compares trabectedin alone with a combination of trabectedin and tTF-NGR, an experimental drug designed to enhance the effectiveness of chemotherapy by concentrating it within the tumor.
The trial is open to adults between 18 and 75 years of age who have high-grade soft tissue sarcoma, including rhabdomyosarcoma, and whose tumors test positive for a specific protein marker called CD13. Patients must have previously received or been unable to receive anthracycline-based treatment. The study represents an opportunity for patients with limited treatment options to access a novel combination therapy approach while contributing to research that may benefit future patients with similar conditions.
