Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy
Breast Cancer
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring recurrent breast cancer
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)
Sites / Locations
- Cleveland Clinic Taussig Cancer Center