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Phase II Trial Of Zileuton In Persons With Bronchial Dysplasia


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Lung Cancer

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Trial Information

Phase II Trial Of Zileuton In Persons With Bronchial Dysplasia


OBJECTIVES:

- Determine the efficacy of zileuton, in terms of number of sites and grade of dysplastic
lesions in the bronchial epithelium, in patients with documented bronchial dysplasia.

- Correlate the regression of bronchial dysplasia (number and grade) and improvement in
sputum cytology with the modulation of molecular biomarkers in patients treated with
this drug.

- Determine the overall toxicity of this drug in these patients.

- Determine the 6-month natural history of bronchial dysplasia in patients who are
randomized to receive treatment with a placebo.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to smoking status (current vs recently quit smoker), and prior cancer
(none vs lung or head and neck). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral zileuton 4 times daily for 6 months in the absence of
disease progression or unacceptable toxicity.

- Arm II: Patients receive oral placebo 4 times daily for 6 months in the absence of
disease progression or unacceptable toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: Approximately 134 patients will be accrued for this study.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Bronchial dysplasia number and grade at 6 months

Safety Issue:

No

Principal Investigator

Omer Kucuk, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000271915

NCT ID:

NCT00056004

Start Date:

June 2003

Completion Date:

March 2009

Related Keywords:

  • Head and Neck Cancer
  • Lung Cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • stage I non-small cell lung cancer
  • stage I squamous cell carcinoma of the hypopharynx
  • stage I squamous cell carcinoma of the larynx
  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage I squamous cell carcinoma of the nasopharynx
  • stage I squamous cell carcinoma of the oropharynx
  • stage II squamous cell carcinoma of the hypopharynx
  • stage II squamous cell carcinoma of the larynx
  • stage II squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the nasopharynx
  • stage II squamous cell carcinoma of the oropharynx
  • Head and Neck Neoplasms
  • Lung Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201