Phenethyl Isothiocyanate in Preventing Lung Cancer in Smokers
Condition: Lung Cancer; Tobacco Use Disorder
MeSH terms: Lung Neoplasms; Tobacco Use Disorder
Intervention: phenethyl isothiocyanate; placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Phenethyl isothiocyanate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: non-small cell lung cancer; small cell lung cancer; tobacco use disorder

Summary:

      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use
      of phenethyl isothiocyanate may prevent lung cancer in people who smoke cigarettes.

      PURPOSE: This randomized clinical trial is studying phenethyl isothiocyanate to see how well
      it works in preventing lung cancer in smokers.
    

Eligibility criteria:

        Inclusion criteria:

        Initial from phone interview:

          -  Currently smoking 10-45 cigarettes per day for the past year;

          -  Between the ages of 21 and 70 years;

          -  In apparently good physical health with no unstable medical conditions including
             seizures or cancer;

          -  In stable and good mental health, i.e., currently do not experience unstable or
             untreated psychiatric diagnosis, including substance abuse, as determined by the
             DSM-IV criteria, during the past six months;

          -  Not using any other tobacco or nicotine-containing products;

          -  Not on methadone maintenance or stimulants such as ephedra; not a regular user of
             street drugs and if uses occasionally, willing to abstain during the study; not taking
             any drugs known to be P4501A6 substrates such as phenobarbital, rifampicin,
             dexamethasone, ketoconazole, methoxsalen, pilocarpine, or tranylcypromine due to their
             role in NNK metabolism;

          -  Does not average more than 21 alcoholic drinks per week;

          -  Willing to perform study activities such as having blood sample drawn, urine
             collection, multiple clinic visits;

          -  For female subjects of child bearing potential, not known to be pregnant or nursing,
             or planning to become pregnant within next 12 months.

        For enrollment in the Short-Term Trial:

          -  Subjects who are generally healthy with liver enzyme and blood count values within the
             ranges shown below based on blood samples drawn at the second screening visit.
             Specifically:

               -  White blood cells ≥ 3,000/mL

               -  Total bilirubin ≤ 1.5 x upper limits of normal (ULN)

               -  AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN

               -  BUN and serum creatinine ≤ 1.5 x ULN

        For enrollment in the Long-Term Trial:

          -  Participated in the short-term trial and invited to participate in the long-term
             trial;

          -  Possess the GSTM1 null-null genotype;

          -  Smoke 20 or more cigarettes/day with a cumulative smoking history of 20 or more
             pack-years (one pack-year equals to smoking a pack of cigarettes a day for one year);

          -  Normal liver enzymes based on blood sample drawn during 1 month wash-out;

          -  Determined to be a good candidate for the bronchoscopy procedure by a primary care
             physician.

        Exclusion Criteria:

          -  Subjects with uncontrolled hypertension, uncontrolled diabetes mellitus, unstable
             coronary artery disease, history of cancer other than non-melanoma skin cancer, and
             pregnant or lactating women will not be eligible.