In the first cohort, 27 patients with recurrent anaplastic gliomas or glioblastoma received carboxyamidotriazole orotate combined with temozolomide. In the second cohort, 15 patients with newly diagnosed glioblastoma (1 with anaplastic astrocytoma) received carboxyamidotriazole orotate with radiotherapy and temozolomide, followed by temozolomide .
In cohort 1, treatment-related adverse events of any grade were fatigue (52%), nausea (41%), and constipation (37%) with no grade 3 or 4 events reported. In cohort 2, the most common treatment-related adverse events were fatigue (67%), nausea (53%), constipation (47%), radiotherapy-related dermatitis (33%), thrombocytopenia (27%), and skin rash (27%). The most common grade 3 event was febrile neutropenia (13%).
In cohort 1, responses were observed in 7 / 27 patients, including 1 complete response, and including responses in O6-methylguanine-DNA methyltransferase unmethylated and bevacizumab-refractory tumors. Among the 15 patients in cohort 2, median progression-free survival was 15 months and median overall survival was not reached over a median follow-up of 28 months; 2-year overall survival was 62%. Among 9 evaluable patients with measureable disease, response was observed in 3 (33%), with complete response in 1.
The PI concluded that Carboxyamidotriazole can be combined safely with temozolomide or chemoradiation in glioblastoma and anaplastic gliomas.
Original Article from the ASCO post