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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Ethanol; Perilla alcohol; Perillyl alcohol

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)