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

NCT ID: NCT00022425

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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recurrent breast cancer

Study Design

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Primary Study Purpose

PREVENTION

Interventions

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perillyl alcohol

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Principal Investigators

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George Thomas Budd, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

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Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CCF-IRB-3574

Identifier Type: -

Identifier Source: secondary_id

CCF-N01-CN-55131

Identifier Type: -

Identifier Source: secondary_id

NCI-P01-0189

Identifier Type: -

Identifier Source: secondary_id

CDR0000068816

Identifier Type: -

Identifier Source: org_study_id