Overview

Isotretinoin in Preventing Skin Cancer

Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Treatments:
Isotretinoin
Criteria
DISEASE CHARACTERISTICS: Diagnosis of autosomal recessive disorder xeroderma pigmentosum
Diagnosis must be documented by the clinical signs and symptoms listed in standard text
books, e.g.: Sun sensitivity Increased number of freckles and other pigmentary lesions
Cutaneous atrophy and telangiectasia Actinic keratoses Skin cancers Ocular abnormalities
(e.g., photophobia, conjunctivitis, keratitis, or premalignant or malignant tumors of the
eye or lid) allowed Neurologic abnormalities (e.g., progressive hearing loss, diminished
reflexes, or progressive mental deterioration) allowed OR Diagnosis of autosomal dominant
nevoid basal cell carcinoma syndrome Diagnosis must be documented by the clinical signs and
symptoms listed in standard text books, e.g.: Basal cell carcinomas Palmar pits Skeletal
abnormalities Falx calcification History of at least 2 documented skin cancers a year
during the 2 years before study, but currently clear of all skin cancer Patients not
previously treated with isotretinoin must agree to undergo a 1 year follow-up period
without isotretinoin (to facilitate observation of any chronic toxicity and observe for new
tumors) Must undergo appropriate treatment for any skin cancers that arise during study No
evidence of metastatic cancer

PATIENT CHARACTERISTICS: Age: Over 2 Hematopoietic: Complete blood cell counts normal
Hepatic: SGOT or SGPT less than 3 times upper limit of normal (ULN) Triglycerides less than
200 mg/dL Renal: Creatinine less than 3 times ULN Cardiovascular: No New York Heart
Association class III or IV heart disease Other: No hypersensitivity to parabens (used in
drug formulation) No proven active malignancy except skin cancer Not pregnant Negative
pregnancy test Fertile patients must use effective contraception during and for 1 month
after study therapy

PRIOR CONCURRENT THERAPY: See Disease Characteristics No recent, chronic, high-dose vitamin
A use (greater than 30,000 IU/day) No concurrent supplemental vitamin A No other concurrent
therapy for the skin (except sunscreens) unless approved by the investigators