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Acitretin in Treating Patients With Skin Disease or Skin Cancer - Article


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Clinical Trial: Acitretin in Treating Patients With Skin Disease or Skin Cancer

This study is no longer recruiting patients.

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
actinic keratosis
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
skin metastases
squamous cell carcinoma of the skin
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
basal cell carcinoma of the skin
 Drug: acitretin
Phase II

MedlinePlus related topics:  Lymphoma;   Skin Cancer;   Skin Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Acitretin in Patients With Psoriasis, Cutaneous Disorders of Keratinization, Multiple Basal Cell Carcinomas, or other Retinoid-Responsive Diseases or Malignancies

Further Study Details: 

Study start: December 2001

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.

PROTOCOL 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

Criteria

PROTOCOL 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--

--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

Location Information


Maryland
      Intramural Research Program, Bethesda,  Maryland,  20892,  United States

Study chairs or principal investigators

John J. DiGiovanna,  Study Chair,  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068733; NCI-77-AR-0172
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00020956
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

Resources



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November 25, 2009



Page Updated: June 1, 2005
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