Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation

Not Applicable

Completed

• Conditions: Non-melanomatous Skin Cancer
• Interventions: Drug: acitretin; Other: placebo

• Registration Number: NCT00003611
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of acitretin may be an effective way to prevent the recurrence or further development of skin cancer.

PURPOSE: Randomized clinical trial to study the effectiveness of acitretin in preventing skin cancers in patients with at least two previously treated skin cancers who have undergone organ transplantation.

Detailed Description

OBJECTIVES:

* Determine the chemopreventive efficacy of acitretin in immunosuppressed solid organ transplant recipients with a history of multiple previous basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) skin cancer resections.

* Evaluate human papillomavirus (HPV) as a possible etiologic cofactor in the development of cutaneous epidermal dysplasia/carcinoma from skin tissues of these patients.

* Determine the effect of acitretin on potential surrogate endpoint biomarkers and HPV DNA in normal (sun protected), sun-exposed, and dysplastic and carcinoma (SCC/BCC) skin specimens.

OUTLINE: This is a randomized study. Patients are stratified according to age (at least 18 to under 50 vs 50 to 59 vs 60 to 69 vs 70 and over), number of prior skin cancers in past 5 years (2 vs 3 vs at least 4), time since most recent skin cancer occurrence (less than 12 months vs at least 12 months), sunburn susceptibility (none vs moderate vs high), visible skin damage (mild vs moderate vs severe).

Patients receive either oral acitretin or placebo daily for 2 years. Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies.

Patients are followed every 6 months.

Study Timeline

• Study First Submitted: 1999-11-01
• Study Start: 2000-05
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-02
• Study Completion: 2003-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acitretin	acitretin	Patients receive oral acitretin daily for 2 years. Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies. Patients are followed every 6 months.
placebo	placebo	Patients receive placebo daily for 2 years. Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies. Patients are followed every 6 months.

Primary Outcome Measures

Name	Time	Method
rate of new primary nonmelanoma skin cancers	Up to 1.5 years

Trial Locations

Locations (11)

CentraCare Health Plaza; 🇺🇸 Saint Cloud, Minnesota, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

CCOP - Scottsdale Oncology Program; 🇺🇸 Scottsdale, Arizona, United States

Rapid City Regional Hospital; 🇺🇸 Rapid City, South Dakota, United States

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

CCOP - Illinois Oncology Research Association; 🇺🇸 Peoria, Illinois, United States

CCOP - Iowa Oncology Research Association; 🇺🇸 Des Moines, Iowa, United States

CCOP - Sioux Community Cancer Consortium; 🇺🇸 Sioux Falls, South Dakota, United States

Medcenter One Health System; 🇺🇸 Bismarck, North Dakota, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States