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.

Condition	Treatment or Intervention	Phase
prevention of skin cancer basal cell carcinoma of the skin squamous cell carcinoma of the skin	Drug: eflornithine	Phase III

Further Study Details: 

OBJECTIVES: I. Compare the rate of new skin cancer in patients with previously treated stage 0 or I 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.

PROTOCOL 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.

Ages Eligible for Study:  21 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven previously treated stage 0 or I basal or squamous cell skin cancer

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Not specified
• Endocrine therapy: Not specified
• Radiotherapy: Greater than 4 weeks since prior radiotherapy
• Surgery: Greater than 4 weeks since prior major surgery
• Other: At least 4 weeks since prior topical medications (e.g., tretinoin, isotretinoin, psoralen ultraviolet light therapy, or fluorouracil) for 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

Study chairs or principal investigators

Paul P. Carbone,  Study Chair,  University of Wisconsin Comprehensive Cancer Center   

Study ID Numbers:  CDR0000067928; WCCC-CO-9737; NCI-P00-0155
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005884
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08