Iloprost in Preventing Lung Cancer in Former Smokers
Condition: Lung Carcinoma
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): Iloprost; Placebo Administration; Quality-of-Life Assessment; Questionnaire Administration
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): Given via inhalation; Given via inhalation; Ancillary studies; Ancillary studies
Other intervention name(s): Ciloprost; Iloprost Clathrate; Ventavis; ZK 36374; Quality of Life Assessment
Intervention MeSH terms: Iloprost
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention