Completed

Chemoprevention Trial of Acitretin Versus Placebo in Solid Organ Transplant Recipients With Multiple Prior Treated Skin Cancers

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What is being tested

acitretin

+ placebo

DrugOther
Who is being recruted

Carcinoma+3

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: May 2000
See protocol details

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: July 13, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2000

Actual date on which the first participant was enrolled.

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.

NCT00003611
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: July 13, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

129 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CarcinomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Basal CellCarcinoma, Basal Cell

Criteria

DISEASE CHARACTERISTICS: Solid organ recipient (kidney, liver, heart, lung, or pancreas) receiving immunosuppressive agents (e.g., prednisone, other corticosteroid, azathioprine, cyclosporine, tacrolimus, mycophenolate mofetil) At least 6 months since transplant At least 2 prior (same event or separate events) basal cell carcinomas (BCC) or squamous cell carcinomas (SCC) resected All visible BCC and SCC resected PATIENT CHARACTERISTICS: Age: 18 and over Life expectancy: Greater than 2 years Hematopoietic: WBC at least 3400/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10.0 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN SGOT no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use two effective forms of birth control for at least 1 month before, during, and at least 3 years after study No history of oral retinoid intolerance No significant, uncontrolled hyperlipidemia No other significant medical condition or threatened allograft rejection state where retinoid use would be contraindicated PRIOR CONCURRENT THERAPY: Other: At least 1 year since prior retinoids No concurrent oral vitamin A supplements, topical retinoids, or other potentially irritating skin preparations No alcohol during and for 2 months after study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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.

Group II

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 11 locations

CCOP - Scottsdale Oncology Program

Scottsdale, United StatesOpen CCOP - Scottsdale Oncology Program in Google Maps

Mayo Clinic

Jacksonville, United States

CCOP - Illinois Oncology Research Association

Peoria, United States

CCOP - Carle Cancer Center

Urbana, United States
Completed11 Study Centers