Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293280
Status:
COMPLETED
Last Update Posted:
2013-05-06
First Post:
2006-02-16
Brief Title:
Lomustine in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase II Study of CCNU Lomustine in Patients With Advanced Non-Small Cell Lung Cancer and Aberrant Hypermethylation of the MGMT Gene
Status:
COMPLETED
Status Verified Date:
2013-05
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 Drugs used in chemotherapy such as lomustine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well lomustine works in treating patients with stage III or stage IV non-small cell lung cancer
PURPOSE This phase II trial is studying how well lomustine works in treating patients with stage III or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the response rate to lomustine in patients with stage IIIB or IV non-small cell lung cancer with aberrant methylation of the MGMT gene
Determine whether the response rate in these patients is significantly greater than that of the historical control
Secondary
Collect preliminary data on toxicity disease stabilization time to disease progression and overall survival
Tertiary
Evaluate the association between clinical outcome and immunohistochemical staining by grouping the patients as complete or partial loss of MGMT gene
OUTLINE This is a multicenter study
Patients receive oral lomustine once on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study
Primary
Evaluate the response rate to lomustine in patients with stage IIIB or IV non-small cell lung cancer with aberrant methylation of the MGMT gene
Determine whether the response rate in these patients is significantly greater than that of the historical control
Secondary
Collect preliminary data on toxicity disease stabilization time to disease progression and overall survival
Tertiary
Evaluate the association between clinical outcome and immunohistochemical staining by grouping the patients as complete or partial loss of MGMT gene
OUTLINE This is a multicenter study
Patients receive oral lomustine once on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WCCC-CO-00501 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |
| JHOC-J0336 | None | None | None |
| WIRB-20031229 | None | None | None |