What is the purpose of this study?
The primary goals of this research study are:
- To determine the maximum tolerated dose of Fenretinide (4-HPR, NSC 374551) Lym-X-Sorb™LXS) Oral Powder (4-HPR/LXS oral powder) given orally, BID, for seven consecutive days every three weeks, in patients with recurrent and/or resistant neuroblastoma.
- To define the toxicities of 4-HPR/LXS oral powder given on this schedule.
- To determine the plasma pharmacokinetics of 4-HPR given on this schedule.
The secondary goals of this research study are:
- To determine the response rate to 4-HPR/LXS oral powder in patients with recurrent and/or resistant neuroblastoma within the confines of a Phase I study.
- To determine the level of 4-HPR delivered as 4-HPR/LXS oral powder in normal peripheral blood mononuclear cells (PBMC) as a tumor cell surrogate tissue.