Perillyl Alcohol in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

December 12, 2019 updated by: University of Wisconsin, Madison

A Phase II Trial of Perillyl Alcohol (NSC 641066) Administered Daily In Patients With Metastatic Androgen Independent Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different way to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol in treating patients with metastatic prostate cancer that has not responded to hormone therapy with androgens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Evaluate the clinical effectiveness of oral perillyl alcohol given to patients with androgen independent metastatic prostate cancer. II. Assess the toxicity of this treatment in these patients.

OUTLINE: Patients receive oral perillyl alcohol 4 times a day for 4 weeks. Patients continue treatment in the absence of severe toxicity and disease progression. Patients are followed every 3 months for survival after disease progression.

PROJECTED ACCRUAL: This study will accrue 20-40 patients in approximately 2 years.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Freeport, Illinois, United States, 61032
        • Leonard C. Ferguson Cancer Center
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3453
        • Green Bay Oncology, Ltd.
      • Janesville, Wisconsin, United States, 53545
        • Mercy Health System
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Comprehensive Cancer Center
      • Madison, Wisconsin, United States, 53715
        • Meriter Hospital
      • Milwaukee, Wisconsin, United States, 53201-0342
        • Sinai Samaritan Medical Center - Milwaukee
      • Wausau, Wisconsin, United States, 54401
        • North Central Oncology Associates, S.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS: Histologically confirmed progressive metastatic or progressive regional nodal adenocarcinoma of the prostate Regression of tumor following hormone therapy If on antiandrogen therapy, must fail to respond to withdrawal or have progressive disease following withdrawal of antiandrogen No CNS disease

PATIENT CHARACTERISTICS: Age: Not specified Performance status: WCCC 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil count at least 1200/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times normal Renal: Creatinine no greater than 1.5 times upper limit of normal Other: At least 5 years since prior malignancy other than: Inactive nonmelanoma skin cancer Adequately treated stage I or II cancer in complete remission No other serious illness No spinal cord compression symptoms

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy required Endocrine therapy: Failed one secondary hormonal manipulation for metastatic disease Concurrent testicular androgen suppression (LHRH) allowed No concurrent hormonal therapy other than LHRH agonist At least 4 weeks since antiandrogen treatment in order to evaluate for response withdrawal Radiotherapy: At least 4 weeks since prior radiation therapy No prior strontium therapy Surgery: No prior orchiectomy Other: No concurrent cholesterol lowering agents No concurrent supplemental vitamins No concurrent antioxidants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1998

Primary Completion (Actual)

October 1, 2001

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 20, 2004

First Posted (Estimate)

July 21, 2004

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066113
  • R03CA073906 (U.S. NIH Grant/Contract)
  • WCCC-CO-9685
  • NCI-T97-0067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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