Ongoing Clinical Trials for Peripheral Primitive Neuroectodermal Tumour of Soft Tissue
There is currently 1 ongoing clinical trial for peripheral primitive neuroectodermal tumour of soft tissue. This trial is investigating targeted radiopharmaceutical therapy for children with somatostatin receptor-positive tumors, including various types of solid tumors and lymphomas. The study is being conducted across multiple European locations and focuses on determining the safest and most effective dosage for pediatric patients.
Clinical trial locations
- France
- Italy
- Spain
Study to Find the Right Dose and Safety of Lutetium (177Lu) Edotreotide and Arginine-Lysine in Children with Somatostatin Receptor-Positive Tumors
This trial is designed for children aged 2 to 17 years who have somatostatin receptor-positive tumors. These are a specific type of tumor that shows markers called somatostatin receptors on their surface. The tumors may include neuroendocrine tumors, certain types of lymphoma, central nervous system tumors, and other solid tumors that have not responded to at least one previous treatment.
Who can participate:
- Children between 2 and 17 years old with confirmed somatostatin receptor-positive tumors
- The tumor must have returned after previous treatment or not responded to at least one earlier therapy
- The child must be able to perform daily activities, measured by a Karnofsky score of at least 50% for those over 16, or a Lansky score of at least 50% for younger children
- If the child previously received certain heart-affecting treatments, their heart function must show an ejection fraction of 55% or higher
- A recent scan must show that the tumor absorbs more radioactivity than the liver
- Recent CT or MRI scans of the tumor must be available
- Written consent from parents or legal guardians is required, along with the child’s agreement to participate
Who cannot participate:
- Children younger than 2 years old
- Children whose tumors do not have somatostatin receptors
- Those who have not tried at least one previous treatment
- Children whose overall health condition makes them unable to safely receive the treatment
- Pregnant or breastfeeding patients
- Those with other medical conditions that could interfere with the study treatment
- Children unable to follow study procedures or attend required visits
What the trial involves:
The study is investigating lutetium Lu 177 edotreotide, a targeted radiopharmaceutical therapy. This treatment uses a radioactive substance that specifically targets tumor cells with somatostatin receptors. By attaching to these receptors, the therapy delivers radiation directly to the cancer cells while minimizing damage to healthy surrounding tissue. Along with this main treatment, children also receive an arginine-lysine solution through an intravenous infusion to help protect the kidneys during therapy.
The main goal of the trial is to determine the right dose of lutetium Lu 177 edotreotide for children. Researchers will carefully monitor how safe the treatment is and how the body processes it. The study involves several treatment cycles with regular check-ups to monitor the children’s health, assess any side effects, and measure how well the treatment is working in reducing tumor size.
The treatment is given directly into a vein through an intravenous infusion. Throughout the study, children undergo regular imaging tests and blood tests to track how the treatment affects their body and the tumor. The trial is expected to continue for several years to gather enough information about the safest and most effective dosage for treating these types of tumors in children.
Summary
Currently, there is one active clinical trial available for children with peripheral primitive neuroectodermal tumour of soft tissue and related somatostatin receptor-positive tumors. This international study is being conducted in three European countries: France, Italy, and Spain. The trial represents an important research effort to find effective treatments for rare pediatric tumors that have not responded to standard therapies.
The focus of this research is on lutetium Lu 177 edotreotide, a specialized form of targeted radiopharmaceutical therapy. This approach is particularly notable because it aims to deliver treatment directly to tumor cells while protecting healthy tissue. The trial’s primary objective is to establish safe and effective dosing specifically for children, addressing a significant gap in treatment options for these rare tumors in pediatric patients.
