Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005849
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2000-06-02
Brief Title:
Bryostatin 1 Plus Paclitaxel in Treating Patients With Stage IIIB Stage IV or Recurrent Non-small Cell Lung Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Phase II Study of Bryostatin-1 in Combination With Paclitaxel for Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of bryostatin 1 plus paclitaxel in treating patients who have stage IIIB stage IV or recurrent non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of bryostatin 1 plus paclitaxel in treating patients who have stage IIIB stage IV or recurrent non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the overall partial and complete response rates in patients with stage IIIB-IV or recurrent non-small cell lung cancer treated with bryostatin 1 and paclitaxel II Determine the overall survival and time to tumor progression in patients treated with this regimen III Determine the T cell subset analysis and serum levels of interleukin-6 and tumor necrosis factor alpha in these patients after receiving bryostatin 1 and correlate with clinical endpoints
OUTLINE This is a multicenter study Patients receive paclitaxel IV over 1 hour on days 1 8 and 15 and bryostatin 1 IV over 1 hour on days 2 9 and 16 Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity Patients are followed for at least 2 years for survival
PROJECTED ACCRUAL A total of 15-40 patients will be accrued for this study within 1 year
OUTLINE This is a multicenter study Patients receive paclitaxel IV over 1 hour on days 1 8 and 15 and bryostatin 1 IV over 1 hour on days 2 9 and 16 Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity Patients are followed for at least 2 years for survival
PROJECTED ACCRUAL A total of 15-40 patients will be accrued for this study within 1 year
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-T99-0018 | None | None | None |
| UCCRC-10337 | None | None | None |