NCT00204789已完成2 期
Phase 2b Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients (OTR)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>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
排除标准
- •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)
结局指标
主要结局
To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability
时间窗: for 12 months
次要结局
- To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50%(for the 12 months of therapy)
- To determine if DFMO will be able to decrease polyamine levels in skin biopsies(for the 12 months of treatment)
研究者
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