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A Phase I - Part B Multiple Dose Trial of Phenethyl Isothiocyanate

Phase 1
Not Enrolling
Lung Cancer

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Trial Information

A Phase I - Part B Multiple Dose Trial of Phenethyl Isothiocyanate

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

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.

Inclusion 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


Type of Study:


Study Design:

Primary Purpose: Prevention

Principal Investigator

Leonard Liebes, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Lung Cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • Lung Neoplasms