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

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: perillyl alcohol


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: perillyl alcohol|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent breast cancer