Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The Cleveland Clinic
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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)
Clareo Health | Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy
