Clinical Trials for Metastatic Osteosarcoma
There are currently 4 clinical trials exploring new treatment options for patients with metastatic osteosarcoma. These studies are investigating innovative medications and treatment combinations aimed at improving outcomes for this aggressive form of bone cancer that has spread to other parts of the body. The trials are being conducted across multiple European countries, including Spain, Italy, France, and Poland.
Clinical trial locations
- France
- Italy
- Poland
- Spain
Study on the Safety and Tumor-Fighting Effects of OMO-103 for Patients with Advanced Osteosarcoma
This trial, conducted in Spain, is evaluating a new medication called OMO-103 (also known as Omomyc) for patients with advanced high-grade osteosarcoma. The treatment is delivered directly into the bloodstream through intravenous infusion.
Who can participate: Patients aged 12 years or older with confirmed advanced high-grade osteosarcoma that cannot be treated with local therapies. The disease must have progressed after at least one, but no more than two, previous chemotherapy treatments containing cisplatin and anthracycline. The cancer must be measurable using imaging tests like CT or MRI scans. Patients over 16 years old need to provide a fresh tumor sample. Both male and female participants must agree to use effective birth control starting at least one menstrual cycle before treatment and continuing for three months after the last dose.
Who cannot participate: Patients with other types of cancer besides high-grade osteosarcoma, those outside the specified age range, vulnerable populations requiring special protection, and anyone unable to follow study procedures or take the medication as required are excluded.
Study focus: The main goal is to evaluate the safety of OMO-103 and measure progression-free survival at 16 weeks. The study will monitor tumor response using imaging techniques, assess side effects through routine tests and physical examinations, and evaluate the impact on patients’ quality of life using specific questionnaires. OMO-103 works by inhibiting the Myc protein, which plays a role in cancer cell growth and survival.
Study on the Effectiveness of Denosumab with Chemotherapy (Cisplatin, Methotrexate, Doxorubicin) for Patients with Metastatic Osteosarcoma
This Italian trial is investigating whether adding denosumab to standard chemotherapy can improve outcomes for patients with metastatic osteosarcoma. The chemotherapy regimen includes three drugs: cisplatin, methotrexate, and doxorubicin hydrochloride, all given through intravenous infusion.
Who can participate: Patients between 12 and 40 years old (or those who have reached skeletal maturity, meaning their bones are fully developed) with confirmed high-grade metastatic osteosarcoma. Patients must have an ECOG Performance status of 2 or less, or a Lansky Score of 40% or more, which measure the ability to perform daily activities. Adequate bone marrow, liver, and kidney function is required, along with a heart function measurement (Left Ventricular Ejection Fraction) greater than 50%. Female patients of childbearing age must have a negative pregnancy test before each chemotherapy cycle, and both male and female participants must use effective birth control.
Who cannot participate: Patients without metastatic osteosarcoma, those outside the specified age range, and vulnerable populations are excluded.
Study focus: The primary goal is to measure 5-year event-free survival, which refers to the time patients remain free from cancer progression or recurrence. Participants will be randomly assigned to receive either standard chemotherapy alone or standard chemotherapy combined with denosumab. Denosumab targets a specific protein involved in bone destruction, potentially helping to prevent cancer spread to bones. The study is expected to conclude in April 2031.
Study on the Effectiveness and Safety of Regorafenib for Patients with Metastatic Bone Sarcomas
This French trial is examining the medication regorafenib for treating metastatic bone sarcomas. Regorafenib is taken orally as a film-coated tablet and works by inhibiting multiple protein kinases involved in tumor growth and blood vessel development that supplies the tumor.
Who can participate: Patients must have a confirmed diagnosis of CIC-rearranged sarcoma, a rare and aggressive type of cancer characterized by specific genetic changes. Children over 12 years old must have a Karnofsky scale score of 60% or higher, and children 12 years old or younger must have a Lansky scale score of 60% or higher. Patients must have normal bone marrow, kidney, and liver function, a life expectancy of more than 3 months, and measurable disease on CT scans. Participants must have had no more than three previous chemotherapy treatments, be at least 10 years old, have a body surface area of at least 1.30 square meters, and show disease progression. Women who can have children and male patients must agree to use effective birth control during the study and for 3 months after treatment. Patients must be part of the Social Security System.
Who cannot participate: Patients with different types of cancer than bone sarcoma, those outside the specified age range, pregnant or breastfeeding patients, those participating in another clinical trial, and those who have had certain recent treatments that might affect the study are excluded.
Study focus: The study will evaluate the non-progression rate at specific time points, such as 8 weeks for certain sarcomas, using RECIST 1.1 criteria to measure changes in tumor size. Secondary outcomes include progression-free survival and overall survival. The study is expected to continue until September 2026.
Study on the Effectiveness and Safety of Regorafenib for Patients with Resistant Primary Bone Tumors
This Polish trial is studying regorafenib for patients with refractory primary bone tumors, including Ewing’s sarcoma and osteosarcoma, that have not responded to previous treatments. The medication is taken orally as a film-coated tablet.
Who can participate: Patients between 9 and 21 years old with Ewing’s sarcoma or osteosarcoma confirmed by tissue examination. The cancer must have not responded to previous treatments or have returned, identified no earlier than 30 days before starting the study. Patients must have a life expectancy of at least 12 weeks, be able to swallow tablets, and if in puberty, must agree to use effective birth control during treatment and for at least 2 years afterward.
Who cannot participate: Patients without refractory primary bone tumors, those outside the specified age range, pregnant or breastfeeding patients, those participating in another clinical trial, and those with allergies to the study medication are excluded.
Study focus: The trial aims to determine if regorafenib can help control the disease and improve quality of life. The dosage is adjusted to achieve drug exposure similar to that recommended for adults, especially for patients aged 9 to 18 years. Regular assessments include monitoring vital signs, laboratory tests, echocardiography, and ECG to evaluate safety. The study is estimated to conclude by December 31, 2025.
Summary
These four clinical trials represent important research efforts to find more effective treatments for metastatic osteosarcoma and related bone sarcomas. The studies are geographically diverse, taking place in Spain, Italy, France, and Poland, providing access to patients across different European countries.
A notable feature is that two of the trials focus on regorafenib, a multikinase inhibitor, suggesting significant interest in this medication as a potential treatment option. The other trials investigate different approaches: OMO-103, which targets the Myc protein involved in cancer cell growth, and denosumab combined with standard chemotherapy, which aims to prevent bone destruction and cancer spread.
The trials include patients ranging from children as young as 9 years old to adults up to 40 years, reflecting the fact that osteosarcoma primarily affects teenagers and young adults. All studies emphasize careful monitoring of safety and effectiveness, with regular assessments using imaging tests and laboratory evaluations. These trials offer hope for patients whose cancer has not responded to conventional treatments or has spread to other parts of the body.
