Iloprost in Preventing Lung Cancer in Former Smokers

Status Completed

Clinical Trial Summary

This phase I trial studies the side effects and best dose of iloprost compared with a placebo in preventing lung cancer in former smokers. Chemoprevention is the use of drugs to keep cancer from forming or coming back. Inhaled iloprost may help prevent lung cancer from forming in patients who used to smoke and who have been found to have abnormal cells in their mucus.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To evaluate the toxicity of inhalational iloprost administered to patients daily for 2 months, given four times a day (QID). SECONDARY OBJECTIVES: I. To evaluate the compliance QID dosing regimens. II. To evaluate the effect on endobronchial histology. III. To evaluate the effect on expectorated sputum cytology by both standard cytologic analysis and an automated three-dimensional morphologic analysis. IV. To evaluate the effect on endobronchial brushing and biopsy gene expression of peroxisome proliferator-activated receptor gamma (PPARgamma), glutathione S-transferase mu (GSTmu), carboxylesterase 1 (Ces1), Fos-related antigen 1 (FosL1), cytochrome p4502e1, stearoyl coA desaturase 1, tumor necrosis factor (TNF) superfamily member 9, transforming growth factor beta (TGFbeta), Jun and a 46 gene panel associated with dysplasia persistence, using Affymetrix arrays. V. To evaluate the improvement in chronic obstructive pulmonary disease (COPD) as measured by arterial blood gas (ABG) (improved ventilation perfusion matching), pulmonary function testing, 6-minute walk distance, quality of life (St. George's respiratory questionnaire, COPD assessment test [CAT]). VI. To evaluate whether the in vitro response of cultured airway epithelial progenitor cells to iloprost is a predictor of in vivo response in study subjects. OUTLINE: Patients are enrolled to Cohort A to completion prior to initiation of Cohort B. COHORT A: Patients are assigned to 1 of 2 arms. ARM I: Patients receive iloprost via inhalation using a nebulizer QID for 60 days. ARM II: Patients receive placebo via inhalation using a nebulizer QID for 60 days. COHORT B: Patients are assigned to 1 of 2 arms. COHORT B DISCONTINUED AS OF 03/26/2019. ARM III: Patients receive iloprost via inhalation using a nebulizer BID for 60 days. ARM IV: Patients receive placebo via inhalation using a nebulizer BID for 60 days. After completion of study treatment, patients are followed up at 90 days and then annually for up to 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02237183
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 1
Start date	November 5, 2015
Completion date	August 30, 2023

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