Melanoma (Skin) Clinical Trial
Official title:
Use Of Isotretinion For Prevention Of Skin Cancer In Patients With Xeroderma Pigmentosum Or Nevoid Basal Cell Carcinoma Syndrome
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.
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.
;
Primary Purpose: Prevention
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