Phenethyl Isothiocyanate in Preventing Lung Cancer in People Who Smoke
Клучни зборови
Апстракт
Опис
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.
Датуми
| Последен пат проверено: | 02/28/2011 |
| Прво доставено: | 06/01/2000 |
| Поднесено е проценето запишување: | 04/26/2004 |
| Прво објавено: | 04/27/2004 |
| Последното ажурирање е доставено: | 03/24/2011 |
| Последно ажурирање објавено: | 03/27/2011 |
| Проценет датум на примарно завршување: | 03/31/2001 |
Состојба или болест
Интервенција / третман
Drug: phenethyl isothiocyanate
Фаза
Критериуми за подобност
| Полови квалификувани за студии | All |
| Прифаќа здрави волонтери | Да |
| Критериуми | 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 |
