Know Cancer

or
forgot password

Use Of Isotretinion For Prevention Of Skin Cancer In Patients With Xeroderma Pigmentosum Or Nevoid Basal Cell Carcinoma Syndrome


N/A
2 Years
N/A
Not Enrolling
Both
Melanoma (Skin), Non-melanomatous Skin Cancer

Thank you

Trial Information

Use Of Isotretinion For Prevention Of Skin Cancer In Patients With Xeroderma Pigmentosum Or Nevoid Basal Cell Carcinoma Syndrome


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Prevention

Principal Investigator

John J. DiGiovanna, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000076973

NCT ID:

NCT00025012

Start Date:

June 1991

Completion Date:

February 2004

Related Keywords:

  • Melanoma (Skin)
  • Non-melanomatous Skin Cancer
  • basal cell carcinoma of the skin
  • squamous cell carcinoma of the skin
  • melanoma
  • Basal Cell Nevus Syndrome
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Melanoma
  • Xeroderma Pigmentosum

Name

Location

Intramural Research ProgramBethesda, Maryland  20892