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| Sponsor: | The Cleveland Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022425 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: perillyl alcohol |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention |
| Official Title: | Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol |
| Study Start Date: | June 2001 |
OBJECTIVES:
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195-9001 | |
| Study Chair: | George T. Budd, MD | The Cleveland Clinic |
More Information
| Study ID Numbers: | CDR0000068816, CCF-IRB-3574, CCF-N01-CN-55131, NCI-P01-0189 |
| Study First Received: | August 10, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00022425 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent breast cancer |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Perilla alcohol Physiological Effects of Drugs Breast Neoplasms Central Nervous System Depressants Enzyme Inhibitors |
Pharmacologic Actions Anti-Infective Agents, Local Neoplasms Neoplasms by Site Therapeutic Uses Central Nervous System Agents Breast Diseases Ethanol |