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Prostacyclin Analogue
Iloprost for Preventing Lung Cancer in Former Smokers
Phase 2
Waitlist Available
Led By Seema Khan
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Former smokers (> 12 months abstinent and confirmed by serum cotinine) with at least a 30 pack-year cigarette history
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial will test whether the drug iloprost can prevent lung cancer in former smokers. Iloprost has been shown to reduce abnormal lung cells in former smokers, so it may help lower the risk of developing cancer.
Who is the study for?
This trial is for former smokers who have been smoke-free for over a year, with a history of heavy smoking (at least 30 pack-years), and either COPD or abnormal lung cells. They must be disease-free lung cancer survivors, at least 50 years old, able to undergo bronchoscopy safely, and meet certain health criteria like adequate blood counts.Check my eligibility
What is being tested?
The study tests if oral Iloprost can prevent lung cancer in ex-smokers by reducing abnormal lung cells. Participants will receive either Iloprost or a placebo and undergo various assessments including questionnaires, biopsies during bronchoscopy, and biospecimen collection to evaluate the drug's effectiveness.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions similar to those seen in other trials involving Iloprost such as headache, flushing, jaw pain or nausea. The procedure-related risks involve bleeding from biopsy sites or discomfort from bronchoscopy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I quit smoking over a year ago after smoking for 30 or more years.
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I am mostly self-sufficient and can carry out daily activities.
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I have chronic obstructive pulmonary disease (COPD).
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I am at least 50 years old.
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I can safely have a bronchoscopy procedure.
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My lung biopsy shows early signs of abnormal cells.
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I had a lung biopsy showing moderate to severe abnormal cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bronchoscopy
Secondary outcome measures
Change in the average WHO score of all biopsy sites with a baseline score of 4 or greater
Incidence of adverse events with oral iloprost
Other outcome measures
Change in glass opacity (GGOs) volume
Histologic response by alternative criteria
In vitro response of bronchial epithelial progenitor cells cultured at the air-liquid interface
+3 moreSide effects data
From 2020 Phase 2 trial • 28 Patients • NCT022301895%
Pregnancy identified during study enrollment
5%
Increased systolic blood pressure post-bronchoscopy
5%
Respiratory infection post-bronchoscopy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Allergic Asthmatics(AA)
Allergic Non-Asthmatics(ANA)
Non-Allergic Non-Asthmatics(NANA)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (iloprost)Experimental Treatment5 Interventions
Patients receive Iloprost PO BID for a 180 days in the absence of unacceptable toxicity. Patients undergo bronchoscopy with biopsies and brushings at day 180.
Group II: Arm II (placebo)Placebo Group5 Interventions
Patients receive placebo PO BID for a 180 days in the absence of unacceptable toxicity. Patients undergo bronchoscopy with biopsies and brushings at day 180.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Bronchoscopy
2002
Completed Phase 2
~2300
Iloprost
2010
Completed Phase 4
~1180
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,073 Total Patients Enrolled
Seema KhanPrincipal InvestigatorNorthwestern University
8 Previous Clinical Trials
487 Total Patients Enrolled
York E MillerPrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
34 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking medication to prevent blood clots.My biopsy shows early or invasive cancer with a score of 7 or 8.I survived stage III NSCLC or any stage SCLC treated with the intent to cure.Your platelet count is at least 100,000 per microliter.I quit smoking over a year ago after smoking for 30 or more years.I am mostly self-sufficient and can carry out daily activities.Your creatinine level must be less than or equal to 2.0 mg/dl.I am currently on hormone or immune therapy, including BCG.I have chronic obstructive pulmonary disease (COPD).Your total bilirubin level is less than or equal to 2.0 mg/dl.I am at least 50 years old.Your AST and ALT levels are not more than 2.5 times the normal limit.I can safely have a bronchoscopy procedure.Patients who show a certain type of abnormality called ground glass opacity on a CT scan that meets specific conditions.My lung biopsy shows early signs of abnormal cells.I had a lung biopsy showing moderate to severe abnormal cells.I had early-stage lung cancer, was treated with surgery, and have been disease-free for over a year.I am taking blood thinners other than aspirin.You have a high level of white blood cells in your blood.I have cancer that has spread to other parts of my body.You have had allergic reactions to similar drugs as iloprost.I have had radiation therapy on my chest or head/neck, or received immunotherapy.Your systolic blood pressure is less than 95 mm Hg.I need extra oxygen (4 liters/min) to keep my oxygen levels above 90%.I haven't had any invasive cancer except skin cancer in the last year.I am not pregnant or breastfeeding while receiving iloprost treatment.I do not have any uncontrolled illnesses.I am not currently on experimental drugs nor have I used iloprost before.You have used any form of tobacco or nicotine inhalation device in the last year.I have a known bleeding disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (iloprost)
- Group 2: Arm II (placebo)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment still open for enrollment?
"As evidenced by the clinicaltrials.gov platform, this medical trial is not currently enrolling patients. The investigation was initiated on January 23rd 2023 and its most recent revision happened on August 4th 2022. However, there are over 4000 other trials actively seeking participants at present."
Answered by AI
What precautions should be taken when performing Bronchoscopy on patients?
"After thorough assessment, our team at Power have assigned a score of 2 to the safety profile of Bronchoscopy as there is some evidence for its security but no proof that it works."
Answered by AI
How many facilities offer access to this research trial?
"This clinical trial is presently recruiting patients from 5 sites, located in Richmond, Pittsburgh and Denver as well as two other places. It would be advantageous to select the closest site, thus reducing travel burdens if you choose to take part."
Answered by AI
Who else is applying?
What site did they apply to?
Hunter Holmes McGuire Veterans Administration Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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