Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006457
Status:
COMPLETED
Last Update Posted:
2012-06-11
First Post:
2000-11-06
Brief Title:
Oltipraz in the Prevention of Lung Cancer in People Who Smoke
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Clinical Phase I Multiple-Dose Safety Research Study of Oltipraz in Smokers
Status:
COMPLETED
Status Verified Date:
2012-06
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 of cancer
PURPOSE Randomized phase I trial to study the effectiveness of oltipraz in preventing lung cancer in people who smoke
PURPOSE Randomized phase I trial to study the effectiveness of oltipraz in preventing lung cancer in people who smoke
Detailed Description:
OBJECTIVES
Determine the effect of oltipraz on the level of BP-78-diol-910-epoxide BPDE DNA adducts in the lung lining cells macrophages and bronchial epithelial cells of smokers
Determine the tolerability and toxicity of this treatment regimen in these patients
Determine the effect of this treatment regimen on the level of macromolecule adducts in the blood eg BPDE DNA BPDE hemoglobin and 8-hydroxy-deoxyguanine oral lining cells BPDE DNA bladder lining cells 4-aminobiphenyl DNA and lung macrophages 8-hydroxy-deoxyguanine in these patients
Determine the effect of this treatment regimen on the change decrease in activation of NNK as measured by change increase in urinary NNAL plus NNAL glucuronide in these patients
Determine the effect of this treatment regimen on the oxidative state glutathione-S-transferase activity and superoxide dismutase 3 and phase II enzymes in the lungs and blood of these patients
Compare the changes in oxidative state and phase II enzymes with changes in adduct levels in the lungs and blood of these patients
Determine the correlation between oltipraz-induced changes in phase II enzymes and adduct formation with genotypic variation in glutathione-S-transferase isozymes in these patients
Compare the response to this treatment regimen in terms of oxidative state phase II enzymes and adduct formation in the lungs vs the blood in these patients
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to participating center Patients are randomized to one of three treatment arms
Arm I Patients receive an oral placebo weekly
Arm II Patients receive low-dose oral oltipraz weekly
Arm III Patients receive high-dose oral oltipraz weekly Treatment continues for 12 weeks in the absence of unacceptable toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 66 patients 22 per treatment arm will be accrued for this study within 21 months
Determine the effect of oltipraz on the level of BP-78-diol-910-epoxide BPDE DNA adducts in the lung lining cells macrophages and bronchial epithelial cells of smokers
Determine the tolerability and toxicity of this treatment regimen in these patients
Determine the effect of this treatment regimen on the level of macromolecule adducts in the blood eg BPDE DNA BPDE hemoglobin and 8-hydroxy-deoxyguanine oral lining cells BPDE DNA bladder lining cells 4-aminobiphenyl DNA and lung macrophages 8-hydroxy-deoxyguanine in these patients
Determine the effect of this treatment regimen on the change decrease in activation of NNK as measured by change increase in urinary NNAL plus NNAL glucuronide in these patients
Determine the effect of this treatment regimen on the oxidative state glutathione-S-transferase activity and superoxide dismutase 3 and phase II enzymes in the lungs and blood of these patients
Compare the changes in oxidative state and phase II enzymes with changes in adduct levels in the lungs and blood of these patients
Determine the correlation between oltipraz-induced changes in phase II enzymes and adduct formation with genotypic variation in glutathione-S-transferase isozymes in these patients
Compare the response to this treatment regimen in terms of oxidative state phase II enzymes and adduct formation in the lungs vs the blood in these patients
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to participating center Patients are randomized to one of three treatment arms
Arm I Patients receive an oral placebo weekly
Arm II Patients receive low-dose oral oltipraz weekly
Arm III Patients receive high-dose oral oltipraz weekly Treatment continues for 12 weeks in the absence of unacceptable toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 66 patients 22 per treatment arm will be accrued for this study within 21 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 |
|---|---|---|---|
| NCI-P00-0167 | None | None | None |
| NU-00L1 | None | None | None |
| DUMC-000346-00-2 | None | None | None |