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Lead
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically confirmed solid malignancy or lymphoma for which no effective therapy exists
Measurable or evaluable disease
No CNS metastasis unless stable for at least 4 weeks following surgery and/or radiotherapy and no requirement for anticonvulsants
PATIENT CHARACTERISTICS:
Age: Over 18
Performance status: ECOG 0-2
Life expectancy: At least 3 months
ANC at least 1,500
Platelets at least 100,000
Bilirubin no greater than 2.0 mg/dL
AST less than 2.5 times normal
Creatinine clearance at least 50 mL/min
No concurrent cholesterol-lowering agents
No active infection (including HIV)
No concomitant medical condition that precludes study compliance
No pregnant or nursing women
Adequate contraception required of fertile patients
PRIOR CONCURRENT THERAPY:
At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin)
At least 4 weeks since wide-field radiotherapy
Fully recovered from prior surgery
Clareo Health | Perillyl Alcohol in Treating Patients With Refractory Cancer
