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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00022425
First received: August 10, 2001
Last updated: December 17, 2013
Last verified: September 2003
  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 1

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2001
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022425

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-9001
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: George Thomas Budd, MD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

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: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 19, 2014