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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: | Primary Purpose: 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 Thomas Budd, MD | The Cleveland Clinic |
More Information
| ClinicalTrials.gov Identifier: | NCT00022425 History of Changes |
| Other Study ID Numbers: | CDR0000068816, CCF-IRB-3574, CCF-N01-CN-55131, NCI-P01-0189 |
| Study First Received: | August 10, 2001 |
| Last Updated: | March 22, 2010 |
| Health Authority: | United States: Federal Government |
|
recurrent breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Ethanol Perilla alcohol Anti-Infective Agents, Local Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |