Phase I trial of fenretinide Lym-X-Sorb oral powder in adults with solid tumors and lymphomas

Shivaani Kummar, Martin E. Gutierrez, Barry J. Maurer, C. Patrick Reynolds, Min Kang, Hardeep Singh, Sonja Crandon, Anthony J. Murgo, James H. Doroshow

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

Abstract

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/m 2/day divided into 2 daily doses for 7 days, every 21 days, and 800 mg/m 2/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.

Original languageEnglish (US)
Pages (from-to)961-966
Number of pages6
JournalAnticancer research
Volume31
Issue number3
StatePublished - Mar 2011
Externally publishedYes

Keywords

  • Clinical trial
  • Fenretinide
  • LXS oral powder
  • Phase I

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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