Phenethyl Isothiocyanate in Preventing Lung Cancer in People Who Smoke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005883
Recruitment Status : Completed
First Posted : April 28, 2004
Last Update Posted : March 28, 2011
National Cancer Institute (NCI)
Information provided by:
New York University School of Medicine

Brief Summary:

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

Detailed Description:

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)
Primary Purpose: Prevention
Official Title: A Phase I - Part B Multiple Dose Trial of Phenethyl Isothiocyanate
Actual Primary Completion Date : April 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


Information from the National Library of Medicine

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 identifier (NCT number): NCT00005883

Sponsors and Collaborators
New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Leonard Liebes, PhD New York University School of Medicine Identifier: NCT00005883     History of Changes
Other Study ID Numbers: CDR0000067923
P30CA016087 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2004    Key Record Dates
Last Update Posted: March 28, 2011
Last Verified: March 2011

Keywords provided by New York University School of Medicine:
non-small cell lung cancer
small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Phenethyl isothiocyanate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents