Phase I trial of sodium salicylate in patients with myelodysplastic syndromes and acute myelogenous leukemia

Sodium salicylate is an inexpensive, readily available anti-inflammatory agent which inhibits NF-κB in in vitro models. We examined whether it was possible to safely achieve and maintain salicylate levels known to inhibit NF-κB in vitro in 11 patients with MDS or AML taking sodium salicylate. Most patients achieved the target blood salicylate level (20-30 mg/dL) with acceptable toxicity, including reversible grade 1/2 elevations of hepatic transaminases (n = 4) and ototoxicity (n = 4). One patient had grade 3/4 elevations in AST/ALT. This study suggests that sodium salicylate may be safely combined with conventional chemotherapy regimens which are not associated with significant ototoxicity or hepatotoxicity.