Perillyl Alcohol in Treating Patients With Refractory Cancer

National Cancer Institute (NCI)

Status and phase: Completed; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Lymphoma

Treatments: Drug: perillyl alcohol

Study type: Interventional

Funder types: NIH

Identifiers

NCT00002862

NCI-T96-0064D

CDR0000065133

YALE-HIC-8895

Details and patient eligibility

About

Phase I trial to study the effectiveness of perillyl alcohol in treating patients with refractory cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Arm I

Experimental group

Description:

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.

Treatment:

Drug: perillyl alcohol