Perillyl alcohol is one of two monoterpenes under development for possible clinical use as an anticancer agent. Monoterpenes are a class of compounds produced by plants which appear to have multiple cellular effects. One of the most studied effects and a possible mechanism for the observed antitumor effect is inhibition of protein isoprenylation. The antitumor effect of monoterpenes has been shown in vitro and in vivo primarily against mammary carcinoma. This is a phase I study of perillyl alcohol, a drug that will be administered by mouth three times a day for 28 days. The study endpoint will be the determination of a maximum tolerated dose that can be carried forward to phase II studies.
The specific aims of this study are: to determine the maximum tolerated dose of perillyl alcohol administered orally in three equal doses per day for 28 days consecutively; to determine the qualitative and quantitative nature of the toxicities encountered when perillyl alcohol is administered on this schedule; to determine basic pharmacokinetics of perillyl alcohol by study of plasma and urinary levels, and other body fluids when feasible; to investigate the relationship between pharmacokinetic parameters and toxicity of perillyl alcohol; to determine the recommended starting dose for continued clinical trials and the schedule tested; and to evaluate the effect of perillyl alcohol on the following biologic parameters in serum, plasma, peripheral mononuclear cells, or tumor when available: triglycerides, total high density lipoprotein (HDL) and low density lipoprotein (LDL) cholesterol levels, plasma transforming growth factor beta (TGFB) levels, and mannose 6-phosphate/insulin growth factor II (IGF II) receptor status in tumor cells.
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