Acitretin in Treating Patients With Skin Disease or Skin Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

July 11, 2001

Last Updated Date

July 23, 2008

Start Date ^ICMJE

December 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00020956 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Acitretin in Treating Patients With Skin Disease or Skin Cancer

Official Title ^ICMJE

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

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Acitretin may be an effective treatment for skin disease and skin cancer.

PURPOSE: Phase II trial to study the effectiveness of acitretin in treating patients who have skin disease or skin cancer.

Detailed Description

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Non-Melanomatous Skin Cancer

Intervention ^ICMJE

Drug: acitretin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00020956

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068733, NCI-77-AR-0172

Study Sponsor ^ICMJE

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

John J. DiGiovanna, MD

National Cancer Institute (NCI)

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP