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| Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020956 |
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 II |
| MedlinePlus related topics: | Cancer Skin Cancer Skin Conditions |
| Drug Information available for: | Acitretin |
| Study Type: | Interventional |
| Study Design: | 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 |
| Study Start Date: | 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.
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 |
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 More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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| Study ID Numbers: | CDR0000068733, NCI-77-AR-0172 |
| First Received: | July 11, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00020956 |
| Health Authority: | United States: Federal Government |
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