Acitretin in Treating Patients With Skin Disease or Skin Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Melanomatous Skin Cancer
Intervention: acitretin (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Official(s) and/or principal investigator(s):
John J. DiGiovanna, MD, Study Chair, Affiliation: National Cancer Institute (NCI)
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.
Clinical Details
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
Study design: Treatment
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Intramural Research Program, Bethesda, Maryland 20892, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 2001
Last updated: May 23, 2008
|
