Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00003205
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bryostatin 1 in Treating Patients With Stage IV Breast Cancer
Sponsor:
University of Colorado, Denver
Organization:
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:
True
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?: