Eflornithine to Prevent Skin Cancer in Patients With Previously Treated Early Stage Skin Cancer

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

Chemoprevention of Skin Cancers With DFMO: A Controlled, Randomized Clinical Trial

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of eflornithine may be an effective way to prevent the recurrence of or further development of skin cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of eflornithine in preventing skin cancer in patients who have previously received treatment for early stage skin cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare the rate of new skin cancer in patients with previously treated stage 0, I, or II basal or squamous cell skin cancer treated with eflornithine (DFMO) vs placebo. II. Determine whether inhibition of TPA-induced ornithine decarboxylase activity serves as an intermediary marker for response to DFMO in these patients. III. Determine whether inhibition of skin polyamine levels serves as an intermediary marker for response to DFMO in these patients. IV. Assess the long term toxic effects of this treatment in these patients.

OUTLINE: This a randomized, double blind, placebo controlled, multicenter study. Patients receive oral placebo daily for the first 4 weeks. Patients who comply with taking 80-100% of placebo are randomized to one of two treatment arms. Arm I: Patients receive oral eflornithine (DFMO) daily. Arm II: Patients receive an oral placebo daily. Treatment continues for 3-5 years in the absence of unacceptable toxicity. Patients who develop skin cancer during study undergo surgical excision and continue treatment on the arm to which they were originally randomized. Patients are followed every 6 months through year 5.

PROJECTED ACCRUAL: A total of 334 patients (167 per arm) will be accrued for this study over 2 years.

Study Type

Interventional

Phase

  • Phase 3

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

21 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically proven previously treated stage 0, I, or II basal or squamous cell skin cancer

PATIENT CHARACTERISTICS: Age: 21 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 11.0 g/dL Hepatic: Bilirubin no greater than 2 mg/dL SGOT less than 3 times normal Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant clinical hearing loss or use of hearing aid No family history of early retinal blindness or ornithine diaminotransferase deficiency

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplant No concurrent tamoxifen for cancer treatment or prophylaxis Chemotherapy: Greater than 4 weeks since prior chemotherapy No concurrent cytotoxic chemotherapy Endocrine therapy: Greater than 4 weeks since prior hormonal therapy for cancer No concurrent prednisone No concurrent hormonal therapy for cancer treatment or prophylaxis Radiotherapy: Greater than 4 weeks since prior radiotherapy Surgery: Greater than 4 weeks since prior major surgery No prior solid organ transplant Other: At least 4 weeks since prior topical medications (e.g., tretinoin, isotretinoin, psoralen ultraviolet light therapy, or fluorouracil) for skin cancer No concurrent antiseizure medication

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: PREVENTION
  • Allocation: RANDOMIZED

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)

Investigators

  • Study Chair: Paul P. Carbone, MD, University of Wisconsin, Madison

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

Primary Completion (ACTUAL)

December 1, 2000

Study Registration Dates

First Submitted

June 2, 2000

First Submitted That Met QC Criteria

July 23, 2004

First Posted (ESTIMATE)

July 26, 2004

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067928
  • U01CA077158 (NIH)
  • WCCC-CO-9737
  • NCI-P00-0155

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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