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The Evaluation of Oral Acitretin in the Treatment of Psoriasis, Cutaneous Disorders of Keratinization, Multiple Basal Cell Carcinomas and Other Retinoid-Responsive Diseases


Phase 2
N/A
N/A
Open (Enrolling)
Both
Non-Melanomatous Skin Cancer

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Trial Information

The Evaluation of Oral Acitretin in the Treatment of Psoriasis, Cutaneous Disorders of Keratinization, Multiple Basal Cell Carcinomas and Other Retinoid-Responsive Diseases


OBJECTIVES: I. Determine the long-term safety and efficacy of acitretin in patients with
psoriasis, cutaneous disorders of keratinization, multiple basal cell carcinomas, or other
retinoid-responsive diseases or malignancies.

OUTLINE: Patients receive oral acitretin daily in the absence of disease progression or
unacceptable toxicity.

PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of psoriasis, cutaneous disorders of keratinization, or
other retinoid-responsive disorders or malignancies OR Diagnosis of multiple basal cell
carcinomas resulting from one of the following: Nevoid basal cell carcinoma syndrome
Xeroderma pigmentosum Arsenical insecticide exposure Sunlight exposure X-irradiation
Widespread involvement (e.g., psoriasis involving 10% or more of body surface area OR
Severe, recalcitrant localized involvement (e.g., keratoderma palmaris et plantaris)
Female patients must have disease that is severe and recalcitrant to all other standard
therapies

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: No persistently abnormal liver
function tests SGOT or SGPT no greater than 3 times upper limit of normal (ULN) Renal: No
persistently abnormal renal function tests Creatinine no greater than 3 times ULN Other:
No persistent pretreatment hypertriglyceridemia (greater than 300 mg/dL) No significant
neurological, musculoskeletal, or other internal medical disorder that would preclude
retinoid therapy Not pregnant Negative pregnancy test Fertile patients must use effective
contraception during and for 3 years after study

PRIOR CONCURRENT THERAPY: No chronic intake of excessive vitamin A exceeding 25,000 IU/day

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

John J. DiGiovanna, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000068733

NCT ID:

NCT00020956

Start Date:

December 2001

Completion Date:

Related Keywords:

  • Non-melanomatous Skin Cancer
  • basal cell carcinoma of the skin
  • Skin Neoplasms
  • Carcinoma, Basal Cell

Name

Location

Intramural Research ProgramBethesda, Maryland  20892