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

Primary Purpose

Non-melanomatous Skin Cancer

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
eflornithine
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-melanomatous Skin Cancer focused on measuring basal cell carcinoma of the skin, squamous cell carcinoma of the skin

Eligibility Criteria

21 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 2, 2000
    Last Updated
    December 12, 2019
    Sponsor
    University of Wisconsin, Madison
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005884
    Brief Title
    Eflornithine to Prevent Skin Cancer in Patients With Previously Treated Early Stage Skin Cancer
    Official Title
    Chemoprevention of Skin Cancers With DFMO: A Controlled, Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    December 2000 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Wisconsin, Madison
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-melanomatous Skin Cancer
    Keywords
    basal cell carcinoma of the skin, squamous cell carcinoma of the skin

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    eflornithine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul P. Carbone, MD
    Organizational Affiliation
    University of Wisconsin, Madison
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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