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Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation Clinical research trials and Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation. Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation  Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
For Condition: squamous cell carcinoma of the skin,basal cell carcinoma of the skin
Status: No longer recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkPittelkow, Study Chair, Mayo Clinic Cancer Center
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
Additional Information:
Study ID Numbers: CDR0000066688; NCCTG-969251,NCI-P98-0137
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003611
Other Squamous Cell Carcinoma Of The Skin Studies:
1. Acitretin in Treating Patients With Skin Disease or Skin Cancer
2. Celecoxib in Preventing Skin Cancer
3. Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
4. Green Tea Extract in Treating Patients With Actinic Keratosis
Related Studies:
Other squamous cell carcinoma of the skin Clinical Trials
Other Arizona Clinical Trials
Other Scottsdale Clinical Trials
Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
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