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The REGAIN study is a small feasibility/safety trial expected to enroll up to 10 patients with recurrent GBM. The trial is using Alpha DaRT, an investigational alpha-radiation therapy placed directly into the tumor tissue via a minimally invasive stereotactic procedure. Early interim results from the first 3 patients treated in the trial showed two complete MRI responses (using RANO criteria), and the third patient had stable disease with 30% tumor reduction. So far, there has only been one grade 3 adverse event in the trial: a treatment-related seizure with temporary paralysis that resolved with steroids.
While these initial objective imaging responses are exciting, the data should be interpreted cautiously. Longer follow-up will be needed to determine durability of response, survival impact, risks such as radiation necrosis, and whether results can be reproduced in a larger population. More information on the trial can be found HERE.