Ongoing Clinical Trials for Extra-osseous Ewing’s Sarcoma Metastatic
Currently, there is 1 ongoing clinical trial for patients with extra-osseous Ewing’s sarcoma that has spread to other parts of the body (metastatic). This trial is testing different combinations of chemotherapy drugs for patients whose disease has come back after treatment or did not respond to initial treatment. The study is being conducted across 10 European countries.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- Finland
- France
- Italy
- Netherlands
- Norway
- Spain
Study of drug combination therapy for patients with recurrent and primary refractory Ewing Sarcoma
This trial is designed for patients whose Ewing sarcoma has either returned after treatment or did not respond to the first treatment. The study compares several different combinations of chemotherapy drugs to determine which works best.
Main inclusion criteria:
- Patients must be at least 2 years old
- The diagnosis of Ewing sarcoma or Ewing-like sarcoma must be confirmed through tissue examination
- Evidence that the disease has progressed during or after completing treatment
- Patients must be medically fit enough to receive the trial treatment
- Adequate kidney function is required, with a measurement called GFR of 60 or higher
- Imaging tests must be completed within 4 weeks before starting the trial
- For female patients who can become pregnant, a negative pregnancy test is required
- Patients must be willing to use effective birth control during treatment and for 12 months afterward
- For certain treatment options, additional requirements include: adequate liver function, heart function with an ejection fraction of at least 50%, controlled blood pressure, and acceptable protein levels in urine
Main exclusion criteria:
- Patients who have not been diagnosed with Ewing sarcoma
- Patients younger than 6 years old or older than 65 years of age
- Patients whose cancer has not returned or who have not shown resistance to initial treatment
- Patients who cannot undergo systemic therapy that affects the whole body
- Patients who cannot complete the required imaging tests
- Patients with severe medical conditions that would make participation unsafe
- Patients currently participating in other clinical trials that could interfere with this study
- Patients who are pregnant or breastfeeding
- Patients with known allergies to the study medications
- Patients who cannot comply with study requirements or follow-up visits
Focus and goal of the trial:
The main goal of this study is to find out which combination of chemotherapy drugs works best for treating Ewing sarcoma that has returned or did not respond to initial treatment. The trial tests multiple chemotherapy medications, including gemcitabine, docetaxel, irinotecan, temozolomide, topotecan, carboplatin, cyclophosphamide, ifosfamide, etoposide, and lenvatinib. These medications are given in different combinations, either through an intravenous infusion into a vein or as oral capsules taken by mouth.
Treatment cycles typically last several weeks, and some medications are given daily while others are given on specific days. The total treatment can continue for up to 104 weeks, depending on how well it works for each patient.
Throughout the study, doctors monitor the size of tumors using imaging scans to check if the treatment is working. They also track any side effects and measure how long patients live without their disease getting worse. The study also evaluates patients’ quality of life during treatment. Regular monitoring includes checking blood pressure, liver function, kidney function, and heart function for specific treatment groups.
Investigational drugs:
The trial involves several chemotherapy medications: gemcitabine, docetaxel, irinotecan, temozolomide, topotecan, carboplatin, cyclophosphamide, ifosfamide, etoposide, and lenvatinib. These drugs are used in different combinations to find the most effective treatment approach.
Summary
There is currently one major international clinical trial available for patients with extra-osseous Ewing’s sarcoma that has spread to other parts of the body. This trial is notable for its wide geographic reach, being conducted across 10 European countries including Finland, Denmark, Italy, France, Spain, Austria, Norway, Netherlands, Belgium, and Czechia. This broad availability increases the chances that eligible patients in Europe can access the trial.
The study takes a comprehensive approach by testing multiple chemotherapy drug combinations to identify the most effective treatment for patients whose disease has returned or did not respond to initial therapy. The trial is designed for patients aged 2 years and older, making it accessible to both children and adults with this rare cancer.
The trial emphasizes patient safety with careful monitoring of organ function, regular imaging to track disease response, and quality of life assessments. Treatment can continue for up to 104 weeks based on individual patient response, allowing for extended therapy when beneficial.
