Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients

Skin Neoplasms Clinical Trial

Official title:

Phase 2b Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients (OTR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204789
• Other study ID #: 2001-414
• Secondary ID: CO00318
• Status: Completed
• Phase: Phase 2
• Start date: July 2003
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a double blind, placebo controlled study of 52 patients who are at least one-year post-solid organ transplant. Subjects will receive either 12 months of DFMO or a placebo. The specific aims are to determine if DFMO at 500 mg daily will be well tolerated for 12 months and not affect organ transplant viability; will inhibit 12-O-tetradecanoylphorbol-13-acetate (TPA)-induced ornithine decarboxylase (ODC) in skin biopsies by approximately 50% for the 12 months of therapy; and will be able to decrease polyamine levels in skin biopsies for the 12 months of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• >1 year post-solid organ transplant of kidney, liver, pancreas, pancreas/kidney

• Adequate organ function

• Hearing age/gender appropriate

• At high risk for developing skin cancer

• Immunosuppressant levels and doses show stable graft function

Exclusion Criteria:

• Use of concomitant Retin-A, Efudex, Accutane or psoralen and ultraviolet light A (PUVA)

• Systemic therapy for cancer treatment or prophylaxis

• Use of concomitant azathioprine, antiseizure medications, non-steroidal anti-inflammatory drugs [NSAIDs] (other than cardioprotective doses of aspirin)

Related Conditions & MeSH terms

• Post-solid Organ Transplant
• Skin Neoplasms

Intervention

Drug:
• Difluoromethylornithine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability		for 12 months
Secondary	To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50%		for the 12 months of therapy
Secondary	To determine if DFMO will be able to decrease polyamine levels in skin biopsies		for the 12 months of treatment