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Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol


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.

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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Prevention

Principal Investigator

George Thomas Budd, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000068816

NCT ID:

NCT00022425

Start Date:

June 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195