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

拟议的临床试验将涉及吸入性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--先前的临床试验表明，口服伊洛前列素可以逆转支气管异型增生(一种肺癌前驱病变)。由于口服伊洛前列素不再可用，本研究的目标是确定两种不同的吸入伊洛前列素方案是否可以耐受，以及它们是否调节肺癌发生的生物标志物。 这项试验是一项I期试验，给科罗拉多大学丹佛分校(丹佛退伍军人医学中心)的前吸烟者服用两种不同剂量的伊洛前列素，5微克(UCG)，每天四次(QID)或每天两次(BID)，为期两个月。在两个剂量水平中，参与者将被随机给予伊洛前列素或匹配的安慰剂，并在治疗前和治疗后接受支气管镜检查和活检，以便可以检查基于组织的生物标记物。

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