NEO100-01 is a Phase 1/2A study of the monoterpene, perillyl alcohol (NEO100)in patients with recurrent glioblastoma. NEO100 is delivered four times a day by intranasal administration using a nebulizer and nasal mask for up to 6 months. Four escalating doses will be evaluated for tolerability, and the maximum tolerated dose will be extended in the 2A phase for a total of 25 patients. There is no concurrent control. This is the first nasal administration in the US, after prior oral studies with perillyl alcohol proved ineffective. Nasal administration of perillyl alcohol is on-going in Brazil.
NCT: NCT02704858
Locations: University of Wisconsin Hospital and Clinic