Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004144
Status:
COMPLETED
Last Update Posted:
2014-04-24
First Post:
1999-12-10
Brief Title:
Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase I Study of Bryostatin 1 and Gemcitabine Gemzar
Status:
COMPLETED
Status Verified Date:
2014-04
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 I trial to study the effectiveness of bryostatin 1 plus gemcitabine in treating patients who have advanced cancer that has not responded to previous treatment
PURPOSE Phase I trial to study the effectiveness of bryostatin 1 plus gemcitabine in treating patients who have advanced cancer that has not responded to previous treatment
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of gemcitabine when given concurrently with bryostatin 1 to patients with advanced refractory cancer
Access the pattern of toxicity of this drug regimen in this patient population
Determine the objective response rate duration of response and overall survival in patients treated with this drug regimen
Determine the influence of bryostatin 1 on the pharmacokinetics of gemcitabine
OUTLINE This is a dose escalation study
Patients receive gemcitabine IV over 30 minutes immediately followed by bryostatin 1 IV over 24 hours weekly for 3 weeks days 1 8 and 15 Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of gemcitabine and bryostatin 1 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 toxic effects
PROJECTED ACCRUAL Approximately 2-3 patients per month will be accrued for this study
Determine the maximum tolerated dose of gemcitabine when given concurrently with bryostatin 1 to patients with advanced refractory cancer
Access the pattern of toxicity of this drug regimen in this patient population
Determine the objective response rate duration of response and overall survival in patients treated with this drug regimen
Determine the influence of bryostatin 1 on the pharmacokinetics of gemcitabine
OUTLINE This is a dose escalation study
Patients receive gemcitabine IV over 30 minutes immediately followed by bryostatin 1 IV over 24 hours weekly for 3 weeks days 1 8 and 15 Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of gemcitabine and bryostatin 1 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 toxic effects
PROJECTED ACCRUAL Approximately 2-3 patients per month will be accrued for this study
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 |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-Z-2021 | None | None | None |
| NCI-T99-0014 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |