Phenethyl Isothiocyanate in Preventing Lung Cancer in People Who Smoke
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|ClinicalTrials.gov Identifier: NCT00005883|
Recruitment Status : Completed
First Posted : April 28, 2004
Last Update Posted : March 28, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: phenethyl isothiocyanate||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I - Part B Multiple Dose Trial of Phenethyl Isothiocyanate|
|Actual Primary Completion Date :||April 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005883
|Study Chair:||Leonard Liebes, PhD||New York University School of Medicine|