Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005883
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
2000-06-02
Brief Title:
Phenethyl Isothiocyanate in Preventing Lung Cancer in People Who Smoke
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase I - Part B Multiple Dose Trial of Phenethyl Isothiocyanate
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE Phase I trial of phenethyl isothiocyanate in preventing lung cancer in people who smoke
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA016087 | NIH | None | None |
| NYU-9905 | None | None | None |
| NCI-P00-0151 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |