NCT00005883

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2000

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

April 28, 2004

Completed
Last Updated

March 28, 2011

Status Verified

March 1, 2011

First QC Date

June 2, 2000

Last Update Submit

March 25, 2011

Conditions

Keywords

non-small cell lung cancersmall cell lung cancer

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

phenethyl isothiocyanate

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Leonard Liebes, PhD

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2000

First Posted

April 28, 2004

Primary Completion

April 1, 2001

Last Updated

March 28, 2011

Record last verified: 2011-03