Ongoing Clinical Trials for Bone Sarcoma
There are currently 3 clinical trials investigating new approaches to bone sarcoma treatment and diagnosis. These studies are taking place across Europe, including Denmark, Italy, and Spain. The trials explore different aspects of care: advanced imaging techniques to better understand tumor metabolism, maintenance therapy to prevent cancer recurrence in high-risk patients, and combination treatments for advanced disease. Participation criteria vary by study, but most require confirmed diagnosis and specific health status requirements.
Clinical trial locations
- Denmark
- Italy
- Spain
Study of Combined Imaging with Hyperpolarized [1-13C]Pyruvate and Fludeoxyglucose (18F) for Cancer Detection in Patients with Breast Cancer, Neuroendocrine Tumors, Lymphomas, or Sarcomas
This trial is testing a new approach to cancer imaging that combines two different scanning techniques to better understand how tumors use energy. The study is being conducted in Denmark and includes patients with several types of cancer, including sarcomas.
Main inclusion criteria: Participants must be adults aged 18 years or older and have a confirmed diagnosis of breast cancer, neuroendocrine neoplasm, lymphoma, or sarcoma. The tumor must measure at least 1.5 centimeters in size. Both men and women can participate, and patients must be able to provide informed consent.
Main exclusion criteria: The study cannot include people under 18 or over 65 years old. Patients who cannot lie still in a scanner for up to 60 minutes, those with claustrophobia, or those with metal implants incompatible with MRI are excluded. Pregnant or breastfeeding women cannot participate. Other exclusions include severe kidney problems, allergies to imaging substances, recent participation in other experimental drug studies, uncontrolled medical conditions, body weight exceeding 180 kg, or blood glucose levels above 200 mg/dL at the time of imaging.
Focus and goal: The trial aims to determine whether two imaging methods can be performed simultaneously to provide better information about tumor metabolism. Participants will undergo a combined PET/MR scan after receiving two different injectable substances that help visualize how cancer cells process nutrients differently from normal cells. The procedure is performed once per participant.
Investigational agents: The study uses two imaging agents: hyperpolarized [1-13C]pyruvate, which is used in magnetic resonance spectroscopy to visualize metabolic processes in real-time, and 18F-FDG, a radioactive form of glucose used in PET imaging that accumulates in cancer cells because they typically consume more glucose than healthy cells.
Study on Metformin for Patients with Osteosarcoma and Ewing’s Sarcoma at High Risk of Relapse
This trial is investigating whether metformin, a medication commonly used for diabetes, can help prevent cancer from returning in patients with certain types of bone sarcoma. The study is taking place in Italy.
Main inclusion criteria: Patients must be at least 10 years old and weigh 30 kg or more. Those with localized osteosarcoma must have 60% or less necrosis after chemotherapy, completed within 45 days. Patients with osteosarcoma or Ewing’s sarcoma who are disease-free after first relapse and within 45 days of surgery or chemotherapy can participate. Patients must be able to swallow medication and have normal kidney and liver function. Screening must occur within 30 days after chemotherapy or surgery, and treatment must start within 30 days of screening.
Main exclusion criteria: Patients without a bone sarcoma diagnosis or who are not at high risk of relapse cannot participate. Those who are unwilling or unable to follow study procedures, have interfering medical conditions, are pregnant or breastfeeding, or are participating in another clinical trial are excluded.
Focus and goal: The study evaluates how well patients remain free of cancer events when taking metformin as maintenance therapy, compared to past patients who did not receive this treatment. Researchers will monitor patients over time to assess how long they remain cancer-free and check for unexpected side effects. Patient quality of life will also be measured using questionnaires.
Investigational drug: Metformin is taken orally in pill form. While primarily used for type 2 diabetes, it is being tested to see if it can improve outcomes for high-risk bone sarcoma patients by affecting cancer cell metabolism.
Study on Sunitinib and Nivolumab with Chemotherapy for Patients with Advanced Soft Tissue and Bone Sarcomas
This clinical trial is testing combination treatments for advanced forms of soft tissue and bone sarcomas. The study is being conducted in Spain and Italy and is expected to continue until 2025.
Main inclusion criteria: Patients must provide written informed consent and have a confirmed diagnosis of advanced soft tissue or bone sarcomas with measurable disease according to standard criteria. They must have an Eastern Cooperative Oncology Group Performance Status of 0-1, meaning they are either fully active or have some symptoms but can be out of bed for more than half the day. Adequate liver, kidney, heart, and blood function is required, with specific laboratory values for blood cell counts, liver enzymes, kidney function, and heart function. Age requirements range from 12 to 80 years depending on the specific group. Females of childbearing potential must have a negative pregnancy test and agree to use birth control. Tumor tissue samples must be provided for research.
Main exclusion criteria: Patients without a diagnosis of advanced soft tissue or bone sarcomas cannot participate. Those outside the specified age ranges for their assigned group, unable to take the study medications, unable to follow study procedures or attend required visits, or belonging to vulnerable populations who cannot give informed consent are excluded.
Focus and goal: The study aims to find the best dose of sunitinib and nivolumab combination and assess how well it works in stopping cancer progression. Different groups receive different treatment combinations, with some receiving sunitinib and nivolumab together, while others receive nivolumab with chemotherapy drugs like epirubicin and ifosfamide. The trial will evaluate progression-free survival rates, overall survival, safety, and overall response rates.
Investigational drugs: The trial uses several medications: sunitinib, which blocks proteins that promote cancer cell growth; nivolumab, an immunotherapy drug that helps the immune system attack cancer cells; and various chemotherapy drugs including epirubicin, ifosfamide, doxorubicin, and dacarbazine, all of which work by interfering with cancer cell DNA to prevent their growth and division.
Summary
The three ongoing clinical trials for bone sarcoma reflect diverse approaches to improving patient outcomes. Geographically, research activity is concentrated in Southern Europe, with Italy hosting two trials and Spain participating in one, while Denmark contributes a diagnostic imaging study.
The trials address different stages of disease and treatment goals. One study focuses on improving diagnostic imaging techniques to better understand tumor metabolism, another investigates maintenance therapy to prevent recurrence in high-risk patients after initial treatment, and the third explores combination treatments for advanced disease. This range demonstrates the multifaceted approach needed to address bone sarcoma at various disease stages.
A notable trend is the investigation of drugs originally developed for other conditions. Metformin, traditionally used for diabetes, is being repurposed as potential maintenance therapy. Similarly, immunotherapy with nivolumab, which helps the immune system recognize cancer cells, is being combined with traditional chemotherapy and targeted therapies like sunitinib.
Age eligibility varies significantly across trials, with one study including patients as young as 10 years old, reflecting the fact that some bone sarcomas commonly affect children and adolescents. Most trials require good overall health status and adequate organ function, which is standard for studies involving active cancer treatment.
