Isotretinoin in Preventing Skin Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025012
First received: October 11, 2001
Last updated: June 17, 2013
Last verified: November 2007
  Purpose

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.


Condition Intervention
Melanoma (Skin)
Non-melanomatous Skin Cancer
Drug: isotretinoin

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Use Of Isotretinion For Prevention Of Skin Cancer In Patients With Xeroderma Pigmentosum Or Nevoid Basal Cell Carcinoma Syndrome

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 1991
Study Completion Date: February 2004
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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025012

Locations
United States, Maryland
Intramural Research Program
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Study Chair: John J. DiGiovanna, MD National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00025012     History of Changes
Obsolete Identifiers: NCT00005661
Other Study ID Numbers: CDR0000076973, NIAMS-91-AR-0161, NCI-91-C-0161
Study First Received: October 11, 2001
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
basal cell carcinoma of the skin
squamous cell carcinoma of the skin
melanoma

Additional relevant MeSH terms:
Basal Cell Nevus Syndrome
Carcinoma, Basal Cell
Melanoma
Skin Neoplasms
Abnormalities, Multiple
Bone Cysts
Bone Diseases
Bone Diseases, Developmental
Carcinoma
Congenital Abnormalities
Cysts
Genetic Diseases, Inborn
Jaw Cysts
Jaw Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Basal Cell
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplastic Syndromes, Hereditary
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Odontogenic Cysts
Skin Diseases
Stomatognathic Diseases
Isotretinoin

ClinicalTrials.gov processed this record on October 28, 2014