Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Iloprost may be effective in preventing lung cancer. PURPOSE: This randomized phase II trial is studying how well iloprost works in preventing lung cancer in patients who are at high risk for this disease.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 14, 2020 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Prevention
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- University of Colorado, Denver
- Interventions being studied
- Drug: iloprost; Other: placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Current or former smoker with ≥ 20 pack-year history of smoking with no tobacco use within the past 6 months
- Mild atypia or worse on sputum cytology, or
- Bronchial biopsy with mild or worse dysplasia within the past 12 months
- Age 18 and over
- SWOG (Southwest Oncology Group)0-2
- Life expectancy at least 6 months
- Granulocyte count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
- Transaminases ≤ 2.5 times ULN
- Bilirubin ≤ 2.0 mg/dL
- Albumin ≥ 2.5 g/dL
- Creatinine ≤ 1.5 mg/dL
- Well-controlled atrial fibrillation OR rare (\< 2 minutes) premature ventricular contractions allowed
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able and willing to undergo bronchoscopy
- Clinically apparent bleeding diathesis
- Ventricular tachycardia
- Multifocal premature ventricular contractions or supraventricular tachycardias with rapid ventricular response
- Pneumonia or acute bronchitis within the past 2 weeks
- Hypoxemia (\< 90% saturation with supplemental oxygen)
- Pregnant or nursing
- Malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Serious medical condition that would preclude bronchoscopy or study participation
- Clinically active coronary artery disease
- Myocardial infarction within the past 6 weeks
- Chest pain
- Congestive heart failure
- Cardiac dysrhythmia that is potentially life-threatening Exclusion for PRIOR CONCURRENT THERAPY:
- Biologic therapy (Not specified)
- More than 5 years since prior chemotherapy
- More than 6 weeks since prior inhaled steroids
- More than 5 years since prior thoracic radiotherapy
- Surgery (Not specified)
- No prior prostacyclin
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado
- Veterans Affairs Medical Center - DenverDenver, Colorado
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland
- Mayo Clinic Cancer CenterRochester, Minnesota
- UPMC Cancer CentersPittsburgh, Pennsylvania
- Vanderbilt-Ingram Cancer CenterNashville, Tennessee
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 14, 2020. Always confirm current availability with the study team.