Vorinostat in combination with bexarotene in advanced cutaneous T-cell lymphoma: A phase I study

8572 Background: Vorinostat, a histone deacetylase inhibitor, is registered for the treatment of advanced cutaneous T-cell lymphoma (CTCL) in the US. Preclinical studies suggest that vorinostat may enhance the activity of chemotherapeutic or biological anticancer agents in a variety of cancers. This Phase I, multicenter, open-label study systematically evaluated vorinostat combined with the retinoid bexarotene in patients (pts) with advanced CTCL. Methods: Eligible pts were aged ≥18 years with stage ≥IB progressive, persistent, or recurrent CTCL refractory to ≥1 systemic therapy. Primary objective was to determine the maximum tolerated dose (MTD). Phase Ia Part I: dose escalation of vorinostat (200–400 mg/day) and bexarotene (150–300 mg/m2/day); Part II: fixed vorinostat dose (400 mg/day) with bexarotene dose escalation (150–450 mg/day). Cycles were repeated every 28 days for ≤6 cycles. Clinical activity and safety of the combination was also assessed. Results: 23 pts received ≥1 dose of study medication....