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Phenethyl Isothiocyanate in Preventing Lung Cancer in People Who Smoke



Phenethyl Isothiocyanate in Preventing Lung Cancer in People Who Smoke

For Condition: Lung Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Kaplan Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Prevention
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --Prior/Concurrent Therapy-- - Not specified --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
LeonardLiebes,  Study Chair,  Kaplan Cancer Center


Additional Information:
Study ID Numbers:  CDR0000067923;  NCI-P00-0151,NYU-9905
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005883

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