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

NCT00022425 | Unknown Phase 1

• 4 other identifiers: CDR0000068816CCF-IRB-3574CCF-N01-CN-55131NCI-P01-0189
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer

Interventions

perillyl alcohol DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195-9001, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

perillyl alcohol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• George Thomas Budd, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: January 27, 2003
• Study Start: June 1, 2001
• Last Updated: December 18, 2013

Record last verified: 2003-09

Locations

US (1)