A PHASE I STUDY OF PERILLYL ALCOHOL IN PATIENTS WITH REFRACTORY MALIGNANCIES (NSC #641066)
I. Estimate the maximum tolerated dose of perillyl alcohol given chronically three times per
day in patients with refractory malignancies.
II. Describe the toxic effects and pharmacokinetics associated with this regimen.
III. Evaluate any antitumor activity of perillyl alcohol in these patients. IV. Assess the
ability of perillyl alcohol to induce tumor differentiation and reduce telomerase activity
in patients from whom serial biopsies can be obtained.
OUTLINE: This is a dose escalation study to determine the maximum tolerated dose of perillyl
Groups of 3-6 patients receive escalating doses of oral perillyl alcohol three times per day
until the maximum tolerated dose or recommended phase II dose is determined. Treatment at
the assigned dose continues until disease progression or unacceptable toxicity intervenes.
Patients with stable disease after 8 weeks of treatment are removed from study.
Patients are followed for duration of response and survival.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
John R. Murren, MD
United States: Food and Drug Administration
|Yale Comprehensive Cancer Center||New Haven, Connecticut 06520-8028|