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



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

For Condition: recurrent breast cancer
Status: No longer recruiting
Sponsor(s): Cleveland Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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)
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
GeorgeBudd,  Study Chair,  Cleveland Clinic Cancer Center

Cleveland Clinic Taussig Cancer Center
Cleveland,  Ohio,  44195-9001
United States
 


Additional Information:
Study ID Numbers:
  CDR0000068816;  CCF-N01-CN-55131,CCF-IRB-3574,NCI-P01-0189
Study Start Date: 
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022425

Other Recurrent Breast Cancer Studies:
1. High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

2. Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy

3. T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer

4. Pyrazoloacridine in Treating Women With Refractory Metastatic Breast Cancer

5. Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer

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

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