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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
perillyl alcohol
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring recurrent breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Cleveland Clinic Taussig Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 10, 2001
Last Updated
December 17, 2013
Sponsor
The Cleveland Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00022425
Brief Title
Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy
Official Title
Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol
Study Type
Interventional

2. Study Status

Record Verification Date
September 2003
Overall Recruitment Status
Unknown status
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Cleveland Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
recurrent breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
perillyl alcohol

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Thomas Budd, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-9001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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