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

NCT00003611 | Completed

• 3 other identifiers: NCCTG-969251CDR0000066688NCI-P98-0137
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 11

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.

Conditions

Non-melanomatous Skin Cancer

Keywords

basal cell carcinoma of the skin; squamous cell carcinoma of the skin

Outcome Measures

Primary Outcomes (1)

• rate of new primary nonmelanoma skin cancers

  Up to 1.5 years

Study Arms (2)

acitretin

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.

Drug: acitretin

placebo

PLACEBO COMPARATOR

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.

Other: placebo

Interventions

acitretin DRUG

acitretin

placebo OTHER

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Health Plaza

Saint Cloud, Minnesota, 56303, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Related Publications (1)

• 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.

  PMID: 21882176 RESULT

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Acitretin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Mark R. Pittelkow, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: May 1, 2000
• Primary Completion: February 1, 2003
• Study Completion: June 1, 2003
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (11)