Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy

December 17, 2013 updated by: The Cleveland Clinic

Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the recurrence of cancer. The use of perillyl alcohol may be effective in preventing the recurrence of breast cancer.

PURPOSE: Phase I trial to study the effectiveness of perillyl alcohol in preventing the recurrence of breast cancer in women who have been treated with surgery with or without adjuvant therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of perillyl alcohol in women at risk for recurrent breast cancer.
  • Determine the toxicity of this drug in these patients.
  • Determine the single-dose and multiple-dose pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral perillyl alcohol once daily on days 1-28. Treatment continues every 4 weeks for 3 courses.

Cohorts of 6 patients receive escalating doses of perillyl alcohol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience grade 1 toxicity or at least 1 of 6 patients experience grade 2 or greater toxicity.

Patients are followed weekly.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195-9001
        • Cleveland Clinic Taussig Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Personal history of stage Tis, I, II, or IIIA breast cancer
  • Previously treated with definitive resection with curative intent

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 9.0 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • AST and ALT no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 1.5 times ULN

Renal:

  • Creatinine no greater than 1.6 mg/dL

Other:

  • No known malabsorption syndrome
  • No contraindication to perillyl alcohol
  • No hypersensitivity to citrus or soybean products
  • No non-breast malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ
  • No active malignancy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 6 months since prior chemotherapy

Endocrine therapy:

  • Concurrent adjuvant hormonal therapy allowed

Radiotherapy:

  • At least 6 months since prior radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 6 months since prior surgery
  • At least 2 years since prior primary surgery
  • More than 4 weeks since prior surgery requiring general anesthesia, including breast reconstructive surgery

Other:

  • More than 3 months since prior enrollment in a single-dose study of perillyl alcohol
  • More than 3 months since prior enrollment in current study (at a lower dose level)
  • No concurrent vitamin supplements except a daily multivitamin (recommended daily allowance)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Study Registration Dates

First Submitted

August 10, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

September 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068816
  • CCF-IRB-3574
  • CCF-N01-CN-55131
  • NCI-P01-0189

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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