Perillyl Alcohol in Treating Patients With Refractory Cancer

NCT ID: NCT00002862

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-10-31

Brief Summary

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.

Detailed 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.

Conditions

Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

perillyl alcohol

Intervention Type: DRUG

Interventions

perillyl alcohol

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John R. Murren, MD

Role: STUDY_CHAIR

Yale University

Locations

Yale Comprehensive Cancer Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

YALE-HIC-8895

Identifier Type: -

Identifier Source: secondary_id

NCI-T96-0064D

Identifier Type: -

Identifier Source: secondary_id

CDR0000065133

Identifier Type: -

Identifier Source: org_study_id