Phenethyl Isothiocyanate in Preventing Lung Cancer in People Who Smoke
Phenethyl Isothiocyanate in Preventing Lung Cancer in People Who Smoke
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
 development or recurrence of cancer. Phenethyl isothiocyanate may be effective in preventing
 lung cancer in smokers.

 PURPOSE: Phase I trial of phenethyl isothiocyanate in preventing lung cancer in people who
 smoke.
OBJECTIVES: I. Determine the maximum tolerated dose of oral phenethyl isothiocyanate in
 smokers. II. Measure the steady state pharmacokinetics of phenethyl isothiocyanate required
 to maintain a steady state of this substance during the hours of
 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) exposure in these patients. III. Obtain
 preliminary data on the perturbation of NNK metabolism by phenethyl isothiocyanate in these
 patients.

 OUTLINE: Patients complete a questionnaire containing a smoking and dietary log to assess
 cigarette and cruciferous vegetable consumption. Patients receive phenethyl isothiocyanate
 orally 4 times a day for 30 days. Cohorts of 3-6 patients receive escalating doses of
 phenethyl isothiocyanate until the maximum tolerated dose (MTD) is determined. The MTD is
 defined as the dose preceding that at which 2 of 6 patients experience dose limiting
 toxicities. Patients are followed on days 35, 36, and 43.

 PROJECTED ACCRUAL: A total of 15-27 patients will be accrued for this study over 4-6 months.
DISEASE CHARACTERISTICS: Asymptomatic smokers who either refuse to or cannot stop smoking
 Urinary cotinine levels greater than 100 ng/mL Willing to adhere to certain dietary
 restrictions limiting intake of cruciferous vegetables (watercress, broccoli, radishes,
 mustard, brussels sprouts) while on study

 PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life
 expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least
 100,000/mm3 Hepatic: Bilirubin less than 1.6 mg/dL Transaminases less than 2 times normal
 Renal: Creatinine less than 1.6 mg/dL Urinary RBC levels 0-2 Urinary WBC levels at least
 0-2 Pulmonary: No dyspnea at rest Other: No concurrent illness, condition, or symptom that
 would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must
 use effective contraception

 PRIOR CONCURRENT THERAPY: Not specified