Isotretinoin in Preventing Skin Cancer

Not Applicable

Completed

• Conditions: Melanoma (Skin); Non-melanomatous Skin Cancer

• Registration Number: NCT00025012
• Lead Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Isotretinoin may be effective in preventing the development or recurrence of skin cancer.

PURPOSE: Clinical trial to study the effectiveness of isotretinoin in preventing or slowing the growth of skin cancer in patients who have xeroderma pigmentosum or basal cell carcinoma.

Detailed Description

OBJECTIVES: I. Determine the lowest effective dose of oral isotretinoin for long-term therapy that is capable of reducing the rate of formation of new skin cancers in patients with xeroderma pigmentosum or nevoid basal cell carcinoma syndrome. II. Determine the possible side effects associated with long-term use of isotretinoin in this patient population.

OUTLINE: Patients are stratified according to disease type (xeroderma pigmentosum vs nevoid basal cell carcinoma syndrome). Patients not previously treated with isotretinoin receive oral isotretinoin daily for 2 years and then are followed without receiving isotretinoin for 1 year. After the follow-up period, treatment may be resumed if the rate of new skin tumor formation reaches 2 per year provided original eligibility criteria are met. Treatment may be resumed during the follow-up period if the rate of new skin tumor formation increases to the rate observed before study. Patients previously treated with oral isotretinoin continue treatment and are followed to evaluate any long-term effects of treatment.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Study Timeline

• Study Start: 1991-06
• Study First Submitted: 2001-10-11
• Study Completion: 2004-02
• Study First Submitted QC: 2004-02-26
• Study First Posted: 2004-02-27
• Status Verified: 2007-11
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Intramural Research Program; 🇺🇸 Bethesda, Maryland, United States