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

Primary Purpose

Non-melanomatous Skin Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acitretin
placebo
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-melanomatous Skin Cancer focused on measuring basal cell carcinoma of the skin, squamous cell carcinoma of the skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Scottsdale Oncology Program
  • Mayo Clinic
  • CCOP - Illinois Oncology Research Association
  • CCOP - Carle Cancer Center
  • CCOP - Iowa Oncology Research Association
  • CCOP - Wichita
  • Mayo Clinic Cancer Center
  • CentraCare Health Plaza
  • Medcenter One Health System
  • Rapid City Regional Hospital
  • CCOP - Sioux Community Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

acitretin

placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

rate of new primary nonmelanoma skin cancers

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003611
Brief Title
Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
Official Title
Chemoprevention Trial of Acitretin Versus Placebo in Solid Organ Transplant Recipients With Multiple Prior Treated Skin Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
June 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-melanomatous Skin Cancer
Keywords
basal cell carcinoma of the skin, squamous cell carcinoma of the skin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acitretin
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
acitretin
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
rate of new primary nonmelanoma skin cancers
Time Frame
Up to 1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark R. Pittelkow, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CentraCare Health Plaza
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Medcenter One Health System
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57709
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21882176
Citation
Kadakia KC, Barton DL, Loprinzi CL, Sloan JA, Otley CC, Diekmann BB, Novotny PJ, Alberts SR, Limburg PJ, Pittelkow MR. Randomized controlled trial of acitretin versus placebo in patients at high-risk for basal cell or squamous cell carcinoma of the skin (North Central Cancer Treatment Group Study 969251). Cancer. 2012 Apr 15;118(8):2128-37. doi: 10.1002/cncr.26374. Epub 2011 Aug 31.
Results Reference
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Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation

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