Acitretin in Treating Patients With Skin Disease or Skin Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00020956
First received: July 11, 2001
Last updated: July 23, 2008
Last verified: September 2001
  Purpose

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.


Condition Intervention Phase
Non-Melanomatous Skin Cancer
Drug: acitretin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Study Start Date: December 2001
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  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: NCT00020956

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:
No publications provided

ClinicalTrials.gov Identifier: NCT00020956     History of Changes
Other Study ID Numbers: CDR0000068733, NCI-77-AR-0172
Study First Received: July 11, 2001
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Skin Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Acitretin
Keratolytic Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014