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Phase II Study of Acitretin in Patients With Psoriasis, Cutaneous Disorders of Keratinization, Multiple Basal Cell Carcinomas, or other Retinoid-Responsive Diseases or Malignancies (Summary Last Modified 09/2001)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Acitretin in Treating Patients With Skin Disease or Skin Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Closed Any age NCI-77-AR-0172
NCT00020956

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.

Entry 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

Prior/Concurrent Therapy:


No chronic intake of excessive vitamin A exceeding 25,000 IU/day

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

Expected Enrollment

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

Outline

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

Trial Contact Information

Trial Lead Organizations

National Institute of Arthritis and Musculoskeletal and Skin Diseases

John DiGiovanna, MD, Protocol chair
Ph: 301-402-1607
Email: jdigiova@mail.nih.gov

Registry Information

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

Trial Start Date		2001-12-14

Registered in ClinicalTrials.gov		NCT00020956

Date Submitted to PDQ		2001-05-10

Information Last Verified		2001-09-01

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.