acapha in preventing lung cancer in former smokers with bronchial intraepithelial neoplasia

Conditions: Lung Cancer; Precancerous Condition

Summary: rationale: chemoprevention is the use of certain drugs to keep cancer from forming. the use of acapha, a combination of six herbs, may prevent lung cancer from forming in former smokers with bronchial intraepithelial neoplasia. purpose: this randomized phase ii trial is studying the side effects and how well acapha works in preventing lung cancer in former smokers with bronchial intraepithelial neoplasia.

objectives: * determine the efficacy and safety of multi-herbal agent acapha in former smokers with bronchial intraepithelial neoplasia. * evaluate whether acapha can modulate other surrogate endpoint biomarkers of aberrant methylation, cell cycle regulation, apoptosis, as well as phase i and ii enzyme regulation. * establish a library of in vivo confocal microendoscopy images with corresponding histopathology, nuclear morphometry, and other biomarker information to assess the potential of confocal microendoscopy as a nonbiopsy method in assessing the effect of chemoprevention agents. outline: patients are stratified according to gender. patients are randomized to 1 of 2 arms. * arm i: patients receive oral multi-herbal agent acapha twice daily for 6 months. patients achieving a partial response receive an additional 6 months of acapha. * arm ii: patients receive oral placebo twice daily for 6 months. patients achieving a partial response receive an additional 6 months of placebo. patients with progressive disease receive acapha twice daily for 6 months. patients undergo sputum cytology, oral and bronchial brushings, bronchoalveolar lavage, and bronchial tissue biopsies at baseline and at 6 and 12 months. samples are analyzed for histopathological and morphometric cell changes; mib-1 bcl-2, and tunel immunostaining; methylation biomarkers; and gene expression analysis of rna. after completion of study therapy, patients are followed at 1 and 6 months.

Eligibility criteria:
disease characteristics: * one or more areas of bronchial intraepithelial neoplasia (ien) (metaplasia/dysplasia) with a nuclear morphometry index \> 1.36 and a surface diameter \> 1.2 mm on autofluorescence bronchoscopy * atypical sputum cells as determined by computer-assisted image analysis * former smoker (i.e., stopped smoking at least 1 year ago) who has smoked at least 30 pack-years (i.e., 1 pack/day for 30 years or more) * exhaled carbon monoxide level \< 5 ppm * no invasive cancer on bronchoscopy or abnormal spiral chest ct scan suspicious of lung cancer patient characteristics: * ecog performance status 0 or 1 * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * normal renal function tests (bun, creatinine, urinalysis) * normal liver function tests (ast, alt, bilirubin, alkaline phosphatase) * no chronic active hepatitis or liver cirrhosis * no acute bronchitis or pneumonia within the past month * no known reaction to xylocaine * no medical condition that, in the opinion of the investigator, could jeopardize the patient's safety during participation in the study, including any of the following: * acute or chronic respiratory failure * unstable angina * uncontrolled congestive heart failure * bleeding disorder prior concurrent therapy: * not specified

Keywords: non-small cell lung cancer small cell lung cancer squamous lung dysplasia