TY - JOUR T1 - Phase I Trial of Fenretinide Lym-X-Sorb Oral Powder in Adults with Solid Tumors and Lymphomas JF - Anticancer Research JO - Anticancer Res SP - 961 LP - 966 VL - 31 IS - 3 AU - SHIVAANI KUMMAR AU - MARTIN E. GUTIERREZ AU - BARRY J. MAURER AU - C. PATRICK REYNOLDS AU - MIN KANG AU - HARDEEP SINGH AU - SONJA CRANDON AU - ANTHONY J. MURGO AU - JAMES H. DOROSHOW Y1 - 2011/03/01 UR - http://ar.iiarjournals.org/content/31/3/961.abstract N2 - Background: The synthetic retinoid fenretinide (N-(4-hydroxyphenyl)retinamide, 4-HPR) has shown promising anticancer activity in preclinical studies, but its limited oral bioavailability has hindered clinical assessment. A novel lipid matrix, Lym-X-Sorb (LXS), was evaluated to improve fenretinide bioavailability and attain higher plasma concentrations. Patients and Methods: Adults with refractory malignancies were administered fenretinide/LXS oral powder in 2 divided doses over 24 h for 7 consecutive days every 21 days in a standard phase I dose-escalation study with pharmacokinetic analysis. Results: The principal toxicities observed were diarrhea, reversible night blindness, and allergic reaction. The maximum tolerated dose regimens were 1,000 mg/m2/day divided into 2 daily doses for 7 days, every 21 days, and 800 mg/m2/day divided into 3 daily doses for 7 consecutive days, every 21 days. Conclusion: Better fenretinide formulations are needed to improve adult patient acceptability and compliance and to achieve the consistent systemic exposures associated with activity in preclinical models. ER -