PROTOCOL NWU2013-02-01A PHASE I TRIAL OF INHALED ILOPROST FOR THE PREVENTION OF LUNG CANCER IN FORMER SMOKERS

拟议的临床试验将解决吸入伊洛前列素预防肺癌的效用。伊洛前列素是一种很有前途的肺癌化学预防药物-先前的临床试验显示，口服伊洛前列素可逆转支气管发育不良（肺癌前体病变）。由于口服伊洛前列素不再可用，目前研究的目的是确定两种不同的吸入伊洛前列素方案是否可耐受，以及它们是否调节肺癌发生的生物标志物。 该试验是在丹佛的科罗拉多大学（丹佛VA医学中心）对前吸烟者给予两种不同剂量水平的伊洛前列素的I期试验，5微克（ucg）每日四次（QID）或每日两次（BID），持续2个月。在两个剂量水平中的每一个中，受试者将被随机分配至伊洛前列素组或匹配的安慰剂组，并将接受治疗前和治疗后的支气管镜检查和活检，以便检查基于组织的生物标志物

The proposed clinical trial shall address the utility of inhaled iloprost for the prevention of lung cancer. Iloprost is a promising agent for the chemoprevention of lung cancer - a prior clinical trial showed reversion of bronchial dysplasia (a lung cancer precursor lesion) with oral iloprost. Since oral iloprost is no longer available, the goal of the current study is to determine if two different schedules of inhaled iloprost are tolerable and whether they modulate biomarkers of lung carcinogenesis. The trial is a phase I trial of two different dose levels of iloprost, 5 micrograms (ucg) four times daily (QID) or twice daily (BID) given for 2 months to former smokers at the University of Colorado, Denver (Denver VA Medical Center). In each of the two dose levels, participants will be randomized to iloprost or matched placebo and will undergo pre- and post-treatment bronchoscopies with biopsies so that tissue-based biomarkers can be examined