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


Phase 2
21 Years
N/A
Not Enrolling
Both
Post-Solid Organ Transplant, Skin Neoplasms

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability

Outcome Time Frame:

for 12 months

Principal Investigator

Howard H Bailey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

2001-414

NCT ID:

NCT00204789

Start Date:

July 2003

Completion Date:

December 2007

Related Keywords:

  • Post-Solid Organ Transplant
  • Skin Neoplasms
  • Neoplasms
  • Skin Neoplasms

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