Perillyl Alcohol in Treating Patients With Refractory Cancer

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00002862

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Unspecified Adult Solid Tumor, Protocol Specific	Drug: perillyl alcohol	Phase 1

Detailed Description

OBJECTIVES:

Estimate the maximum tolerated dose of perillyl alcohol given chronically three times per day in patients with refractory malignancies.
Describe the toxic effects and pharmacokinetics associated with this regimen.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A PHASE I STUDY OF PERILLYL ALCOHOL IN PATIENTS WITH REFRACTORY MALIGNANCIES (NSC #641066)

Study Start Date :

Oct 1, 1996

Actual Primary Completion Date :

Apr 1, 2001

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: perillyl alcohol

Arm

Intervention/Treatment

Experimental: Arm I

Drug: perillyl alcohol

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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