Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003220
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
1999-11-01
Brief Title:
Bryostatin 1 in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase II Study of Bryostatin 1 in Patients With Metastatic Colo-Rectal Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2013-04
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
PURPOSE Phase II trial to study the effectiveness of bryostatin 1 in treating patients with metastatic colorectal cancer
PURPOSE Phase II trial to study the effectiveness of bryostatin 1 in treating patients with metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Determine the efficacy of bryostatin 1 administered as a 24 hour intravenous infusion every week for 3 weeks during a 4 week course of therapy in patients with colorectal cancer II Determine the response duration time to progression and survival time in this patient population III Determine the qualitative and quantitative toxic effects of bryostatin 1 on this schedule in this patient population
OUTLINE Patients are treated with bryostatin 1 as a 24 hour continuous intravenous infusion weekly for 3 weeks followed by 1 week of rest Courses are repeated every 4 weeks in the absence of unacceptable toxicity or disease progression Patients who have no toxic effects after the completion of the first course of therapy may have the dose of bryostatin 1 escalated by 1 dose level in subsequent courses Patients are followed for response duration and time to treatment failure
PROJECTED ACCRUAL A total of 13-26 patients will be accrued for this study within 18 months
OUTLINE Patients are treated with bryostatin 1 as a 24 hour continuous intravenous infusion weekly for 3 weeks followed by 1 week of rest Courses are repeated every 4 weeks in the absence of unacceptable toxicity or disease progression Patients who have no toxic effects after the completion of the first course of therapy may have the dose of bryostatin 1 escalated by 1 dose level in subsequent courses Patients are followed for response duration and time to treatment failure
PROJECTED ACCRUAL A total of 13-26 patients will be accrued for this study within 18 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-T97-0065 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |
| WSU-D-1457 | None | None | None |