Malignant oligodendroglioma Trials in Disease

Study on the Safety of Aminolevulinic Acid with Ultrasound Therapy for Patients with Newly Diagnosed High-Grade Glioma Before Surgery and Standard Treatment

This clinical trial is exploring a new treatment approach for patients with newly diagnosed high-grade glioma, including malignant oligodendroglioma. The study combines a substance called 5-aminolevulinic acid (5-ALA) with sonodynamic therapy (SDT), which uses ultrasound waves to target cancer cells. This treatment is given before patients undergo surgery to remove the tumor, followed by standard therapy.

Main inclusion criteria:

• Patients must be 18 years or older
• Must have a WHO Performance Status of 0-2, meaning they can still perform daily activities or care for themselves despite having some symptoms
• Must have an MRI scan showing signs of high-grade glioma or confirmed diagnosis of high-grade glioma types, including anaplastic oligodendroglioma
• Cannot have received prior tumor treatments such as surgery (except biopsy), radiation, or chemotherapy
• Must be scheduled for debulking or cytoreductive surgery to remove as much of the tumor as possible
• Must meet specific blood test requirements, including adequate counts of white blood cells, platelets, hemoglobin, and proper liver and kidney function
• Patients of childbearing potential and their partners must agree to use effective birth control during the study and for several months after
• Must be able to understand and provide informed consent

Main exclusion criteria:

• Patients who are not newly diagnosed with high-grade glioma
• Patients who fall outside the specified age range
• Patients who belong to vulnerable populations who may have limited ability to protect their own interests

Focus and goal: The main purpose of this trial is to evaluate the safety and tolerability of combining 5-ALA with sonodynamic therapy in patients with newly diagnosed high-grade glioma. The study will monitor patients for any side effects or adverse reactions for 28 days after treatment. Researchers will use MRI scans to observe changes in the tumor and examine how the treatment affects cancer cells. This trial aims to provide important information about whether this combination could be a potential treatment option for this type of brain tumor.

Investigational drugs: The trial uses two key components: 5-Aminolevulinic Acid (5-ALA), which is given as an oral solution at a concentration of 30 mg/ml, and CV01, which is the delivery method for ultrasound therapy. The 5-ALA medication helps make cancer cells more visible and sensitive to treatment. When combined with ultrasound waves, it is thought to enhance the ability to target and potentially destroy cancer cells. The medication works by converting into a compound that accumulates in tumor cells, making them more responsive to the ultrasound therapy.