The UVA Cancer Center is enrolling patients diagnosed with recurrent glioblastoma (GBM), a type of brain tumor, to participate in a clinical research study. Patients with this type of cancer usually undergo traditional care options including any combination of surgery, radiation, chemotherapy, or receipt of supportive care to help with symptoms.
In this research study, participants will be given an FDA-approved drug called 5-ALA (Gleolan®). This drug is normally used to help surgeons see your tumor tissue during brain surgery. However, in this trial, Gleolan® will be used to destroy tumor cells and potentially reduce the risk of tumor recurrence. This is possible because Gleolan® targets tumor cells and then can be activated using non-invasive focused ultrasound (FUS) to destroy tumor tissue without harming normal tissue nearby. The combination of FUS and 5-ALA is known as Sonodynamic Therapy (SDT), and this will be performed 1 to 3 weeks before your scheduled surgery to remove the tumor. The main purpose of this study is to assess the safety of this combination and to see how well it works for individuals who have recurrent GBM. It should be noted that 5-ALA is not FDA approved for SDT and is investigational, but it has been deemed safe in other groups of patients. Participants will be followed by their provider according to standard clinical practice.
During the study, participants will be expected to complete imaging of their tumor (i.e., one head CT and multiple MRI’s at various time points) prior to their surgery. In addition, participants will be asked to have blood drawn (before and throughout treatment) so that researchers can see if SDT is safe and to look for changes in the immune system and tumor. Participants will be asked to stay overnight in the hospital for observation when they complete SDT. Tumor tissue will also be collected at the time of surgery, which will be performed as part of clinical care for the management of the disease. The tumor tissue will be studied in the laboratory, and genetic sequencing studies will be performed on both tissue and blood samples.
Study-related procedures, including but not limited to some of the imaging procedures, the research analyses of the blood/tissue samples, and study treatment (SDT), will be provided at no cost to participants.
Additional information can be found here: https://clinicaltrials.gov/NCT06039709
Please contact uvacancertrials@uvahealth.org for additional information
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