Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Acitretin in Treating Patients With Skin Disease or Skin Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | Any age | NCI-77-AR-0172 NCT00020956 |
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.
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:
No chronic intake of excessive vitamin A exceeding 25,000 IU/day
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
Expected Enrollment
A total of 130 patients will be accrued for this study.
Outline
Patients receive oral acitretin daily in the absence of disease progression or unacceptable toxicity.
Trial Lead Organizations
National Institute of Arthritis and Musculoskeletal and Skin Diseases
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| John DiGiovanna, MD, Protocol chair | |
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| Registry Information | ||
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| 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 | |
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| Trial Start Date | 2001-12-14 | |
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| Registered in ClinicalTrials.gov | NCT00020956 | |
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| Date Submitted to PDQ | 2001-05-10 | |
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| Information Last Verified | 2001-09-01 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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