NCT00025012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 1991

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1991

Completed
10.4 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 27, 2004

Completed
Last Updated

June 19, 2013

Status Verified

November 1, 2007

First QC Date

October 11, 2001

Last Update Submit

June 17, 2013

Conditions

Melanoma (Skin)Non-melanomatous Skin Cancer

Keywords

basal cell carcinoma of the skinsquamous cell carcinoma of the skinmelanoma

Interventions

isotretinoinDRUG

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Intramural Research Program

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Kraemer KH, DiGiovanna JJ, Moshell AN, Tarone RE, Peck GL. Prevention of skin cancer in xeroderma pigmentosum with the use of oral isotretinoin. N Engl J Med. 1988 Jun 23;318(25):1633-7. doi: 10.1056/NEJM198806233182501.

    PMID: 3287161RESULT

MeSH Terms

Conditions

MelanomaCarcinoma, Basal Cell

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • John J. DiGiovanna, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 11, 2001

First Posted

February 27, 2004

Study Start

June 1, 1991

Study Completion

February 1, 2004

Last Updated

June 19, 2013

Record last verified: 2007-11

Locations

US(1)