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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
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.
Primary Purpose: Treatment
Yale Comprehensive Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:58-0400
RATIONALE: Drugs used in chemotherapy, such as perillyl alcohol, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing....
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of perillyl alco...
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RATIONALE: Drugs used in chemotherapy use different way to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of perillyl alcoh...
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