Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003205
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
1999-11-01
Brief Title:
Bryostatin 1 in Treating Patients With Stage IV Breast Cancer
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
A Phase II Trial of Bryostatin-1 for the Treatment of Stage IV Breast Cancer
Status:
COMPLETED
Status Verified Date:
2002-12
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 stage IV breast cancer
PURPOSE Phase II trial to study the effectiveness of bryostatin 1 in treating patients with stage IV breast cancer
Detailed Description:
OBJECTIVES
Determine the clinical response of patients with stage IV breast cancer to bryostatin 1
Determine the efficacy of this regimen in these patients
Estimate the pharmacokinetic parameters of bryostatin 1 when given as 24 hour infusion
Determine the ability of this regimen to regulate lymphocyte function in these patients
Determine the effect of this regimen on platelet function and protein kinase C activity in these patients
OUTLINE Patients receive bryostatin 1 IV over 24 hours Treatment continues weekly in the absence of disease progression or unacceptable toxicity
Patients are followed every 4-8 weeks for tumor response
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study
Determine the clinical response of patients with stage IV breast cancer to bryostatin 1
Determine the efficacy of this regimen in these patients
Estimate the pharmacokinetic parameters of bryostatin 1 when given as 24 hour infusion
Determine the ability of this regimen to regulate lymphocyte function in these patients
Determine the effect of this regimen on platelet function and protein kinase C activity in these patients
OUTLINE Patients receive bryostatin 1 IV over 24 hours Treatment continues weekly in the absence of disease progression or unacceptable toxicity
Patients are followed every 4-8 weeks for tumor response
PROJECTED ACCRUAL A total of 14-25 patients 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 |
|---|---|---|---|
| NCI-T97-0063 | None | None | None |
| UCHSC-97751 | None | None | None |