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Phenethyl Isothiocyanate in Preventing Lung Cancer in People Who Smoke

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00005883
First received: June 2, 2000
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Lung Cancer
Drug: phenethyl isothiocyanate
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: A Phase I - Part B Multiple Dose Trial of Phenethyl Isothiocyanate

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005883

Sponsors and Collaborators
New York University School of Medicine
National Cancer Institute (NCI)
Investigators
Study Chair: Leonard Liebes, PhD New York University School of Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00005883     History of Changes
Other Study ID Numbers: CDR0000067923  P30CA016087  NYU-9905  NCI-P00-0151 
Study First Received: June 2, 2000
Last Updated: March 25, 2011
Health Authority: United States: Federal Government

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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Phenethyl isothiocyanate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 06, 2016