Lung Cancer Clinical Trial
Official title:
Phase II Trial Of Zileuton In Persons With Bronchial Dysplasia
Verified date | April 2013 |
Source | Barbara Ann Karmanos Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of zileuton may be an effective way to prevent
lung cancer in patients who have bronchial dysplasia.
PURPOSE: Randomized phase II trial to study the effectiveness of zileuton in preventing lung
cancer in patients who have bronchial dysplasia.
Status | Completed |
Enrollment | 38 |
Est. completion date | March 2009 |
Est. primary completion date | September 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - At high risk for dysplasia, defined by 1 of the following criteria: - Current or former smokers who have smoked at least 30 pack-years - Former smokers must be enrolled within 20 years of complete smoking cessation - Patients with curatively treated stage I non-small cell lung cancer* - Patients with curatively treated stage I or II squamous cell carcinoma of the head and neck (limited to oral cavity, pharynx, or larynx)* NOTE: *At least 12 months post-curative therapy - Histologic confirmation of mild to severe bronchial dysplasia on bronchoscopic biopsy required - Moderate or severe atypia on sputum cytology required before bronchoscopy (not required for patients with prior lung or head and neck cancer) - No evidence of malignancy by chest x-ray PATIENT CHARACTERISTICS: Age - 18 and over (for patients with prior lung or head and neck malignancy) - 35 and over (for all other patients) Performance status - SWOG 0-1 Life expectancy - Not specified Hematopoietic - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL - No bleeding disorder Hepatic - Bilirubin no greater than upper limit of normal (ULN) - Liver enzymes no greater than ULN - PT/PTT no greater than ULN - No active or chronic liver disease (even if transaminases have normalized) Renal - Creatinine no greater than ULN Cardiovascular - No unstable angina - No uncontrolled heart failure Pulmonary - No significant asthma or chronic obstructive pulmonary disease requiring chronic or periodic (at least once per year) steroids for flares - No acute or chronic respiratory failure Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Willing and able to undergo serial bronchoscopic examinations - No ongoing alcohol use (i.e., at least 1 glass of wine, beer, or a mixed drink per day on a regular basis) - No other medical condition that would preclude safety during study participation - No other active or invasive malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix - No hypersensitivity to study drug or any of its inactive ingredients PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - More than 3 months since prior corticosteroids* - No concurrent corticosteroids* - No concurrent anticancer hormonal agents NOTE: *Systemic or inhaled, including chronic administration Radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - More than 3 months since prior lipoxygenase inhibitors* - More than 3 months since prior investigational agents - More than 3 months since prior nutritional supplements (except 1 daily multivitamin) - No concurrent nutritional supplements (except 1 daily multivitamin) - No other concurrent lipoxygenase inhibitors* - No other concurrent investigational agents - No concurrent warfarin, beta-blockers, or theophylline - No other concurrent antineoplastic agents - No concurrent or chronic daily use of non-steroidal anti-inflammatory agents (NSAIDS) (except cardioprotective doses of aspirin less than 100 mg/day) - Periodic use of NSAIDS allowed - Concurrent participation in a smoking cessation program (including use of bupropion or nicotine gum or patch) allowed NOTE: *Systemic or inhaled, including chronic administration |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Barbara Ann Karmanos Cancer Institute | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bronchial dysplasia number and grade at 6 months | No | ||
Secondary | Biomarkers (Ki-67, Cyclin D1, bcl-2, bax, caspase-3) by immunohistochemistry at 6 and 12 months | No | ||
Secondary | Biomarkers (5-HETE, LTB-4) by blood and BAL levels at 6 and 12 months | No | ||
Secondary | Adverse events as measured by number and severity monthly | Yes |
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