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| Descriptive Information Fields | |||||
| Brief Title † | Acitretin in Treating Patients With Skin Disease or Skin Cancer | ||||
| 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 | ||||
| Brief 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. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Non-Melanomatous Skin Cancer | ||||
| Intervention † | Drug: acitretin | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database  |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | |||||
| Start Date † | December 2001 | ||||
| Completion Date | |||||
| Eligibility 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 |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00020956 | ||||
| Organization ID | CDR0000068733 | ||||
| Secondary IDs †† | NCI-77-AR-0172 | ||||
| Study Sponsor † | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2001 | ||||
| First Received Date † | July 11, 2001 | ||||
| Last Updated Date | July 23, 2008 | ||||
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