Perillyl Alcohol in Treating Patients With Refractory Cancer

2014-08-27 03:58:58 | BioPortfolio


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of perillyl alcohol in treating patients with refractory cancer.


OBJECTIVES: 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 alcohol. 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.

PROJECTED ACCRUAL: It is expected that 15-25 patients will be entered over 1-2 years.

Study Design

Primary Purpose: Treatment




perillyl alcohol


Yale Comprehensive Cancer Center
New Haven
United States




National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:58:58-0400

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