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

NCT ID: NCT00005884

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Non-melanomatous Skin Cancer

Keywords

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basal cell carcinoma of the skin squamous cell carcinoma of the skin

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

PREVENTION

Interventions

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eflornithine

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul P. Carbone, MD

Role: STUDY_CHAIR

University of Wisconsin, Madison

Other Identifiers

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U01CA077158

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WCCC-CO-9737

Identifier Type: -

Identifier Source: secondary_id

NCI-P00-0155

Identifier Type: -

Identifier Source: secondary_id

CDR0000067928

Identifier Type: -

Identifier Source: org_study_id