<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02237183</url>
  </required_header>
  <id_info>
    <org_study_id>NCI-2014-01891</org_study_id>
    <secondary_id>NCI-2014-01891</secondary_id>
    <secondary_id>N01-CN-2012-00035</secondary_id>
    <secondary_id>HHSN2612201200035I</secondary_id>
    <secondary_id>NCI2013-02-01</secondary_id>
    <secondary_id>NWU2013-02-01</secondary_id>
    <secondary_id>N01CN00035</secondary_id>
    <secondary_id>P30CA060553</secondary_id>
    <nct_id>NCT02237183</nct_id>
  </id_info>
  <brief_title>Iloprost in Preventing Lung Cancer in Former Smokers</brief_title>
  <official_title>A Phase I Trial of Inhaled Iloprost for the Prevention of Lung Cancer in Former Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Institute (NCI)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I trial studies the side effects and best dose of iloprost compared with a placebo&#xD;
      in preventing lung cancer in former smokers. Chemoprevention is the use of drugs to keep&#xD;
      cancer from forming or coming back. Inhaled iloprost may help prevent lung cancer from&#xD;
      forming in patients who used to smoke and who have been found to have abnormal cells in their&#xD;
      mucus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the toxicity of inhalational iloprost administered to patients daily for 2&#xD;
      months, given four times a day (QID).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the compliance QID dosing regimens. II. To evaluate the effect on&#xD;
      endobronchial histology. III. To evaluate the effect on expectorated sputum cytology by both&#xD;
      standard cytologic analysis and an automated three-dimensional morphologic analysis.&#xD;
&#xD;
      IV. To evaluate the effect on endobronchial brushing and biopsy gene expression of peroxisome&#xD;
      proliferator-activated receptor gamma (PPARgamma), glutathione S-transferase mu (GSTmu),&#xD;
      carboxylesterase 1 (Ces1), Fos-related antigen 1 (FosL1), cytochrome p4502e1, stearoyl coA&#xD;
      desaturase 1, tumor necrosis factor (TNF) superfamily member 9, transforming growth factor&#xD;
      beta (TGFbeta), Jun and a 46 gene panel associated with dysplasia persistence, using&#xD;
      Affymetrix arrays.&#xD;
&#xD;
      V. To evaluate the improvement in chronic obstructive pulmonary disease (COPD) as measured by&#xD;
      arterial blood gas (ABG) (improved ventilation perfusion matching), pulmonary function&#xD;
      testing, 6-minute walk distance, quality of life (St. George's respiratory questionnaire,&#xD;
      COPD assessment test [CAT]).&#xD;
&#xD;
      VI. To evaluate whether the in vitro response of cultured airway epithelial progenitor cells&#xD;
      to iloprost is a predictor of in vivo response in study subjects.&#xD;
&#xD;
      OUTLINE: Patients are enrolled to Cohort A to completion prior to initiation of Cohort B.&#xD;
&#xD;
      COHORT A: Patients are assigned to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients receive iloprost via inhalation using a nebulizer QID for 60 days.&#xD;
&#xD;
      ARM II: Patients receive placebo via inhalation using a nebulizer QID for 60 days.&#xD;
&#xD;
      COHORT B: Patients are assigned to 1 of 2 arms. COHORT B DISCONTINUED AS OF 03/26/2019.&#xD;
&#xD;
      ARM III: Patients receive iloprost via inhalation using a nebulizer BID for 60 days.&#xD;
&#xD;
      ARM IV: Patients receive placebo via inhalation using a nebulizer BID for 60 days.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 90 days and then annually&#xD;
      for up to 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 5, 2015</start_date>
  <primary_completion_date type="Actual">March 5, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of clinical toxicity</measure>
    <time_frame>Up to 90 days</time_frame>
    <description>Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Descriptive statistics (mean, standard deviation [SD], median, max, min and range) will be provided for toxicity. Approximate 95% confidence intervals will be used to assess the difference between treatment groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment compliance, measured as the fraction of prescribed inhalations actually administered</measure>
    <time_frame>Up to 60 days</time_frame>
    <description>Descriptive statistics (mean, SD, median, max, min and range) will be provided for compliance. Approximate 95% confidence intervals will be used to assess the difference between treatment groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response of airway histology</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will provide descriptive statistics for the effect on endobronchial histology, with the primary parameter being worst histology at matched sites; additional outcomes will be average histology, dysplasia index and response, as described.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum protein profiling</measure>
    <time_frame>Up to 60 days</time_frame>
    <description>Will provide descriptive statistics for the effect on serum proteins as quantitated by aptamer based analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endobronchial brushing gene expression</measure>
    <time_frame>Up to 60 days</time_frame>
    <description>Will provide descriptive statistics for the effect on endobronchial brushing gene expression, focusing on prostacyclin-targeted pathways.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gene expression of dysplastic lesions</measure>
    <time_frame>Up to 60 days</time_frame>
    <description>Will provide descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in chronic obstructive pulmonary disease (COPD)</measure>
    <time_frame>Up to 60 days</time_frame>
    <description>Will provide descriptive statistics for the improvement in COPD as measured by arterial blood gas (improved ventilation perfusion matching), pulmonary function testing, 6-minute walk distance, and quality of life (St. George's respiratory questionnaire, COPD assessment test).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whether the in vitro response of cultured airway epithelial progenitor cells to iloprost is a predictor of in vivo response in study subjects</measure>
    <time_frame>Up to 60 days</time_frame>
    <description>Bronchial biopsies will be taken from an area suspicious for dysplasia and an area that appears normal. These will be cultured as described and transferred to an air liquid interface culture in which dysplasia is recapitulated. Cultures will be treated with either vehicle or iloprost and assessed for both self-renewal and differentiation to ciliated and secretory cells.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Lung Carcinoma</condition>
  <arm_group>
    <arm_group_label>Arm I (iloprost QID)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive iloprost via inhalation using a nebulizer QID for 60 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (placebo QID)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receive placebo via inhalation using a nebulizer QID for 60 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm III (iloprost BID)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive iloprost via inhalation using a nebulizer BID for 60 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm IV (placebo BID)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receive placebo via inhalation using a nebulizer BID for 60 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iloprost</intervention_name>
    <description>Given via inhalation</description>
    <arm_group_label>Arm I (iloprost QID)</arm_group_label>
    <arm_group_label>Arm III (iloprost BID)</arm_group_label>
    <other_name>Ciloprost</other_name>
    <other_name>Iloprost Clathrate</other_name>
    <other_name>Ventavis</other_name>
    <other_name>ZK 36374</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Administration</intervention_name>
    <description>Given via inhalation</description>
    <arm_group_label>Arm II (placebo QID)</arm_group_label>
    <arm_group_label>Arm IV (placebo BID)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (iloprost QID)</arm_group_label>
    <arm_group_label>Arm II (placebo QID)</arm_group_label>
    <arm_group_label>Arm III (iloprost BID)</arm_group_label>
    <arm_group_label>Arm IV (placebo BID)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (iloprost QID)</arm_group_label>
    <arm_group_label>Arm II (placebo QID)</arm_group_label>
    <arm_group_label>Arm III (iloprost BID)</arm_group_label>
    <arm_group_label>Arm IV (placebo BID)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have either sputum cytologic atypia of mild dysplasia or greater or&#xD;
             a history of bronchial biopsy with mild or greater dysplasia within the past 12 months&#xD;
&#xD;
          -  Participants must have a smoking history of 20 pack-years or greater&#xD;
&#xD;
          -  Participants must have the ability to safely undergo bronchoscopy in the judgment of&#xD;
             the investigators&#xD;
&#xD;
          -  Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =&lt;&#xD;
             1&#xD;
&#xD;
          -  Leukocytes &gt;= 3,000/microliter&#xD;
&#xD;
          -  Platelets &gt;= 100,000/microliter&#xD;
&#xD;
          -  Total bilirubin =&lt; 2.0 mg/dl&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/&#xD;
             alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =&lt; 2.5 x&#xD;
             institutional upper limit of normal (ULN)&#xD;
&#xD;
          -  Creatinine =&lt; 2.0 mg/dl&#xD;
&#xD;
          -  The effects of iloprost on the developing human fetus at the recommended therapeutic&#xD;
             dose are unknown; for this reason and because prostacyclins are known to be&#xD;
             teratogenic, women of child-bearing potential and men having intercourse with a woman&#xD;
             of childbearing potential must agree to use adequate contraception (hormonal or&#xD;
             barrier method of birth control; abstinence) prior to study entry and for the duration&#xD;
             of study participation; should a woman become pregnant or suspect she is pregnant&#xD;
             while participating in this study, she should inform her study physician immediately;&#xD;
             Note: Women are considered to be of child-bearing potential if they are not surgically&#xD;
             sterile or are under the age of 65 and have menstruated within the last two years&#xD;
&#xD;
          -  Participants must be able to understand and willing to sign a written informed consent&#xD;
             document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must not have used any tobacco product in the past year&#xD;
&#xD;
          -  Participants must not be currently receiving or have previously received&#xD;
             thiazolidinedione treatment unless sputum atypia or endobronchial dysplasia are&#xD;
             documented again after thiazolidinedione treatment and within 12 months of entry&#xD;
&#xD;
          -  Participants must not have been treated with iloprost at any time; Note: participants&#xD;
             on the placebo arm of previous iloprost trials are eligible, but participants on the&#xD;
             placebo arm of cohort A of this study may not be enrolled in cohort B&#xD;
&#xD;
          -  Participants must not have used any other investigation agent within the last six&#xD;
             months&#xD;
&#xD;
          -  Participants must not have a history of allergic reactions attributed to compounds of&#xD;
             similar chemical or biologic composition of iloprost&#xD;
&#xD;
          -  Participants must not have uncontrolled intercurrent illness including, but not&#xD;
             limited to, ongoing or active infection, symptomatic congestive heart failure,&#xD;
             unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations&#xD;
             that in the opinion of investigators would jeopardize patient safety of data&#xD;
             integrity; Note: individuals who are human immunodeficiency virus (HIV) positive will&#xD;
             not necessarily be excluded, will be considered on a case-by-case basis, but will be&#xD;
             required to meet criteria related to patient safety and data integrity, as assessed by&#xD;
             investigators&#xD;
&#xD;
          -  Participants must not have a current or prior invasive malignancy within the past 6&#xD;
             months; participants may enroll prior to biopsy result report, unless there are&#xD;
             findings at bronchoscopy suggesting an invasive malignancy; history of the following&#xD;
             curatively treated cancers during any time prior to screening is allowed: non-melanoma&#xD;
             skin cancer, cervical carcinoma in situ, and bladder carcinoma in situ&#xD;
&#xD;
          -  Participants must not have received either chemotherapy or radiotherapy within the&#xD;
             previous 6 months; Note: participants receiving long-term adjuvant hormonal therapy&#xD;
             (such as tamoxifen or aromatase inhibitors for breast cancer) are allowed&#xD;
&#xD;
          -  Women must not be pregnant or breastfeeding; iloprost is a prostacyclin agent with the&#xD;
             potential for teratogenic or abortifacient effects; because there is an unknown but&#xD;
             potential risk for adverse events in nursing infants secondary to treatment of the&#xD;
             mother with iloprost, breastfeeding should be discontinued if the mother is treated&#xD;
             with iloprost&#xD;
&#xD;
          -  As iloprost inhibits platelet function, patients must not be taking anticoagulants,&#xD;
             with the exception of aspirin or other non-steroidal anti-inflammatory medications&#xD;
&#xD;
          -  Due to risk for hypotension in patients on vasodilators or antihypertensive&#xD;
             medications, participants must not have blood pressure &lt; 95 mm Hg systolic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>York E Miller</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80217-3364</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>June 28, 2022</last_update_submitted>
  <last_update_submitted_qc>June 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iloprost</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02237183
org study id: NCI-2014-01891
secondary id: NCI-2014-01891
secondary id: N01-CN-2012-00035
secondary id: HHSN2612201200035I
secondary id: NCI2013-02-01
secondary id: NWU2013-02-01
secondary id: N01CN00035
secondary id: P30CA060553
nct id: NCT02237183
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Incidence of clinical toxicity
time frame: Up to 90 days
description: Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Descriptive statistics (mean, standard deviation [SD], median, max, min and range) will be provided for toxicity. Approximate 95% confidence intervals will be used to assess the difference between treatment groups.
measure: Treatment compliance, measured as the fraction of prescribed inhalations actually administered
time frame: Up to 60 days
description: Descriptive statistics (mean, SD, median, max, min and range) will be provided for compliance. Approximate 95% confidence intervals will be used to assess the difference between treatment groups.
measure: Response of airway histology
time frame: Up to 5 years
description: Will provide descriptive statistics for the effect on endobronchial histology, with the primary parameter being worst histology at matched sites; additional outcomes will be average histology, dysplasia index and response, as described.
measure: Serum protein profiling
time frame: Up to 60 days
description: Will provide descriptive statistics for the effect on serum proteins as quantitated by aptamer based analysis.
measure: Endobronchial brushing gene expression
time frame: Up to 60 days
description: Will provide descriptive statistics for the effect on endobronchial brushing gene expression, focusing on prostacyclin-targeted pathways.
measure: Gene expression of dysplastic lesions
time frame: Up to 60 days
description: Will provide descriptive statistics.
measure: Improvement in chronic obstructive pulmonary disease (COPD)
time frame: Up to 60 days
description: Will provide descriptive statistics for the improvement in COPD as measured by arterial blood gas (improved ventilation perfusion matching), pulmonary function testing, 6-minute walk distance, and quality of life (St. George's respiratory questionnaire, COPD assessment test).
measure: Whether the in vitro response of cultured airway epithelial progenitor cells to iloprost is a predictor of in vivo response in study subjects
time frame: Up to 60 days
description: Bronchial biopsies will be taken from an area suspicious for dysplasia and an area that appears normal. These will be cultured as described and transferred to an air liquid interface culture in which dysplasia is recapitulated. Cultures will be treated with either vehicle or iloprost and assessed for both self-renewal and differentiation to ciliated and secretory cells.
arm group label: Arm I (iloprost QID)
arm group type: Experimental
description: Patients receive iloprost via inhalation using a nebulizer QID for 60 days.
arm group label: Arm II (placebo QID)
arm group type: Placebo Comparator
description: Patients receive placebo via inhalation using a nebulizer QID for 60 days.
arm group label: Arm III (iloprost BID)
arm group type: Experimental
description: Patients receive iloprost via inhalation using a nebulizer BID for 60 days.
arm group label: Arm IV (placebo BID)
arm group type: Placebo Comparator
description: Patients receive placebo via inhalation using a nebulizer BID for 60 days.
intervention type: Drug
intervention name: Iloprost
description: Given via inhalation
arm group label: Arm I (iloprost QID)
arm group label: Arm III (iloprost BID)
other name: Ciloprost
other name: Iloprost Clathrate
other name: Ventavis
other name: ZK 36374
intervention type: Other
intervention name: Placebo Administration
description: Given via inhalation
arm group label: Arm II (placebo QID)
arm group label: Arm IV (placebo BID)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm I (iloprost QID)
arm group label: Arm II (placebo QID)
arm group label: Arm III (iloprost BID)
arm group label: Arm IV (placebo BID)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (iloprost QID)
arm group label: Arm II (placebo QID)
arm group label: Arm III (iloprost BID)
arm group label: Arm IV (placebo BID)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: York E Miller
role: Principal Investigator
affiliation: Northwestern University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Iloprost