CompletedPhase 2NCT00691132

Phenethyl Isothiocyanate in Preventing Lung Cancer in Smokers

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.

Checked against the public recordLast updated May 12, 2017 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations1
SponsorUniversity of Minnesota
01
Study overview

What this study is about

Purpose
Prevention
Study type
Interventional
Phase
Phase 2
Sponsor
University of Minnesota
Interventions being studied
Drug: phenethyl isothiocyanate; Other: placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 12, 2017. Always confirm current availability with the study team.

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