Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Non-melanomatous Skin Cancer |
Drug: acitretin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Prevention |
| Official Title: | Chemoprevention Trial of Acitretin Versus Placebo in Solid Organ Transplant Recipients With Multiple Prior Treated Skin Cancers |
| Estimated Enrollment: | 110 |
| Study Start Date: | May 2000 |
| Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
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.
PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 4-5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Performance status:
- Not specified
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:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
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
Contacts and Locations| United States, Arizona | |
| CCOP - Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Illinois | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Iowa | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| CentraCare Health Plaza | |
| Saint Cloud, Minnesota, United States, 56303 | |
| United States, North Dakota | |
| Medcenter One Health System | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, South Dakota | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57709 | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
| Study Chair: | Mark R. Pittelkow, MD | Mayo Clinic |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003611 History of Changes |
| Other Study ID Numbers: | CDR0000066688, NCCTG-969251, NCI-P98-0137 |
| Study First Received: | November 1, 1999 |
| Last Updated: | September 9, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
basal cell carcinoma of the skin squamous cell carcinoma of the skin |
Additional relevant MeSH terms:
|
Skin Neoplasms Neoplasms by Site Neoplasms Skin Diseases Acitretin |
Keratolytic Agents Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013