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Home > "P" Clinical Trials Conditions > Phenethyl Isothiocyanate in Preventing Lung Cancer in People Who Smoke  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
Other Lung Cancer Studies:
1. Study of S-3304 in Patients with Locally Advanced Non-Small Cell Lung Cancer
2. CI-1040 in Treating Patients With Advanced Breast, Colon, Pancreatic, or Non-Small Cell Lung Cancer
3. Treating Inoperable Lung Tumors With Heated Chemotherapy Medicine Delivered Solely to the Lung
4. Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy
5. Gene Therapy in Treating Patients With Cancer
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Phenethyl Isothiocyanate in Preventing Lung Cancer in People Who Smoke
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