Perillyl Alcohol in Treating Patients With Refractory Cancer

Phase 1

Completed

• Conditions: Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: perillyl alcohol

• Registration Number: NCT00002862
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study Start: 1996-10
• Study First Submitted: 1999-11-01
• Status Verified: 2000-09
• Primary Completion: 2001-04
• Study First Submitted QC: 2004-07-16
• Study First Posted: 2004-07-19
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	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.

Trial Locations

Locations (1)

Yale Comprehensive Cancer Center; 🇺🇸 New Haven, Connecticut, United States