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Lung CarcinomaPhase 1NCT02237183

Iloprost in Preventing Lung Cancer in Former Smokers

A Phase 1 study testing Iloprost, Quality-of-Life Assessment and Questionnaire Administration in people with Lung Carcinoma, run by National Cancer Institute (NCI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Lung Carcinoma
What is being tested?
Iloprost, Quality-of-Life Assessment and Questionnaire Administration
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
2 sitesUnited States
Study dates
5 Nov 2015to 30 Aug 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have either sputum cytologic atypia of mild dysplasia or greater or a history of bronchial biopsy with mild or greater dysplasia within the past 12 months
  • Participants must have a smoking history of 20 pack-years or greater
  • Participants must have the ability to safely undergo bronchoscopy in the judgment of the investigators
  • Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  • Leukocytes >= 3,000/microliter
  • Platelets >= 100,000/microliter
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  • Total bilirubin =< 2.0 mg/dl
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN)
  • Creatinine =< 2.0 mg/dl
  • The effects of iloprost on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because prostacyclins are known to be teratogenic, women of child-bearing potential and men having intercourse with a woman of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately; Note: Women are considered to be of child-bearing potential if they are not surgically sterile or are under the age of 65 and have menstruated within the last two years
  • Participants must be able to understand and willing to sign a written informed consent document

Who cannot join

  • Participants must not have used any tobacco product in the past year
  • Participants must not be currently receiving or have previously received thiazolidinedione treatment unless sputum atypia or endobronchial dysplasia are documented again after thiazolidinedione treatment and within 12 months of entry
  • Participants must not have been treated with iloprost at any time; Note: participants on the placebo arm of previous iloprost trials are eligible, but participants on the placebo arm of cohort A of this study may not be enrolled in cohort B
  • Participants must not have used any other investigation agent within the last six months
  • Participants must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition of iloprost
  • Participants must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that in the opinion of investigators would jeopardize patient safety of data integrity; Note: individuals who are human immunodeficiency virus (HIV) positive will not necessarily be excluded, will be considered on a case-by-case basis, but will be required to meet criteria related to patient safety and data integrity, as assessed by investigators
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  • Participants must not have a current or prior invasive malignancy within the past 6 months; participants may enroll prior to biopsy result report, unless there are findings at bronchoscopy suggesting an invasive malignancy; history of the following curatively treated cancers during any time prior to screening is allowed: non-melanoma skin cancer, cervical carcinoma in situ, and bladder carcinoma in situ
  • Participants must not have received either chemotherapy or radiotherapy within the previous 6 months; Note: participants receiving long-term adjuvant hormonal therapy (such as tamoxifen or aromatase inhibitors for breast cancer) are allowed
  • Women must not be pregnant or breastfeeding; iloprost is a prostacyclin agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with iloprost, breastfeeding should be discontinued if the mother is treated with iloprost
  • As iloprost inhibits platelet function, patients must not be taking anticoagulants, with the exception of aspirin or other non-steroidal anti-inflammatory medications
  • Due to risk for hypotension in patients on vasodilators or antihypertensive medications, participants must not have blood pressure < 95 mm Hg systolic

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • University of Colorado

    Denver, Colorado, 80217-3364

Other trials in United States

About this study

Official title: A Phase I Trial of Inhaled Iloprost for the Prevention of Lung Cancer in Former Smokers

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the toxicity of inhalational iloprost administered to patients daily for 2 months, given four times a day (QID).

SECONDARY OBJECTIVES:

  1. 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.

  1. 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.

Conditions
Lung Carcinoma
Being tested
Iloprost, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IloprostDrug

    Also called Ciloprost, Iloprost Clathrate, Ventavis, ZK 36374

    Given via inhalation

  • Placebo AdministrationOther

    Given via inhalation

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT02237183
Study groupRoleWhat they receive
Arm I (iloprost QID)ExperimentalPatients receive iloprost via inhalation using a nebulizer QID for 60 days.
Receives: Drug: Iloprost; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (placebo QID)Placebo comparatorPatients receive placebo via inhalation using a nebulizer QID for 60 days.
Receives: Other: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm III (iloprost BID)ExperimentalPatients receive iloprost via inhalation using a nebulizer BID for 60 days.
Receives: Drug: Iloprost; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm IV (placebo BID)Placebo comparatorPatients receive placebo via inhalation using a nebulizer BID for 60 days.
Receives: Other: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of clinical toxicity

    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.

    Measured: Up to 90 days

  2. Treatment compliance, measured as the fraction of prescribed inhalations actually administered

    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.

    Measured: Up to 60 days

Secondary outcomes (6)

  1. Response of airway histology

    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.

    Measured: Up to 5 years

  2. Serum protein profiling

    Will provide descriptive statistics for the effect on serum proteins as quantitated by aptamer based analysis.

    Measured: Up to 60 days

  3. Endobronchial brushing gene expression

    Will provide descriptive statistics for the effect on endobronchial brushing gene expression, focusing on prostacyclin-targeted pathways.

    Measured: Up to 60 days

  4. Gene expression of dysplastic lesions

    Will provide descriptive statistics.

    Measured: Up to 60 days

  5. Improvement in chronic obstructive pulmonary disease (COPD)

    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).

    Measured: Up to 60 days

  6. Whether the in vitro response of cultured airway epithelial progenitor cells to iloprost is a predictor of in vivo response in study subjects

    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.

    Measured: Up to 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2014 (estimated)
  2. Study start5 Nov 2015
  3. Primary completion5 Mar 2020
  4. Study completion30 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02237183
Sponsor's protocol ID
NCI-2014-01891
Other IDs
NCI-2014-01891, N01-CN-2012-00035, HHSN2612201200035I, NCI2013-02-01, NWU2013-02-01, N01CN00035, P30CA060553
Status last verified
Nov 2023
First submitted
9 Sep 2014
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Miller YE, Ghosh M, Merrick DT, Kubala B, Szabo E, Bengtson L, Kocherginsky M, Helenowski IB, Benante K, Schering T, Kim J, Kim H, Ha D, Bergan RC, Khan SA, Keith RL. Phase Ib trial of inhaled iloprost for the prevention of lung cancer with predictive and response biomarker assessment. Front Oncol. 2023 Aug 30;13:1204726. doi: 10.3389/fonc.2023.1204726. eCollection 2023.

    PubMed 37711198

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Iloprost, Quality-of-Life Assessment and Questionnaire Administration in people with Lung Carcinoma, run by National Cancer Institute (NCI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of clinical toxicity (time frame: Up to 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02237183, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.

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