Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol
- Determine the maximum tolerated dose of perillyl alcohol in women at risk for recurrent
- Determine the toxicity of this drug in these patients.
- Determine the single-dose and multiple-dose pharmacokinetics of this drug in these
OUTLINE: This is a dose-escalation study.
Patients receive oral perillyl alcohol once daily on days 1-28. Treatment continues every 4
weeks for 3 courses.
Cohorts of 6 patients receive escalating doses of perillyl alcohol until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which
at least 2 of 6 patients experience grade 1 toxicity or at least 1 of 6 patients experience
grade 2 or greater toxicity.
Patients are followed weekly.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Primary Purpose: Prevention
George Thomas Budd, MD
The Cleveland Clinic
United States: Federal Government
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