A PHASE IB STUDY TO ASSESS SAFETY OF CONCURRENT AZELIRAGON WITH CRANIOSPINAL IRRADIATION IN PATIENTS WITH LEPTOMENGINAL METASTASIS FROM SOLID TUMOR MALIGNANCIES OR HIGH-GRADE GLIOMAS

Brief description of study

This study is a Phase 1b clinical trial at a single hospital to test the few side effects and safety of combining the drug Azeliragon with craniospinal irradiation (CSI) in patients with leptomeningeal metastasis from solid tumors or high-grade gliomas. Patients will take Azeliragon for 7 days before starting CSI, continue it during CSI, and take it for 7 more days afterward. The study will test different doses to find the amount with the fewest side effects, based on any issues during the first 4 weeks of treatment. Once the best dose is found, additional patients will be treated at that level. Patients will have regular check-ups, including brain and spine MRIs and spinal fluid tests, during treatment and at 4 weeks, 3 months, 6 months, 9 months, and 12 months after finishing CSI. The study will also track survival, cancer progression, and patient-reported symptoms. Patients can continue other treatments, like chemotherapy or immunotherapy, after finishing radiation, and their progress will be followed until death.


Clinical Study Identifier: s24-00982
ClinicalTrials.gov Identifier: NCT06724926
Principal Investigator: Jonathan Tzu-l Yang.
Other Investigators: Minerva A Utate, Kara Micah Banson, Alexandra M. Miller, Alexandra Gewirtz, Dimitris G Placantonakis, Jessica Goggin, Erik P. Sulman, Douglas S. Kondziolka, Daniel A. Orringer, Benjamin Cooper, Ryan C Mitchell, Marissa Barbaro, Joshua S. Silverman, Maria Del Pilar Guillermo Prieto Eibl, Jose Ricardo McFaline Figueroa.


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