Bryostatin 1 in Treating Patients With Stage IV Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00003205|
Recruitment Status : Completed
First Posted : April 23, 2003
Last Update Posted : May 30, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: bryostatin 1||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Trial of Bryostatin-1 for the Treatment of Stage IV Breast Cancer|
|Study Start Date :||April 1998|
|Actual Primary Completion Date :||April 2004|
|Actual Study Completion Date :||April 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003205
|United States, Colorado|
|University of Colorado Cancer Center|
|Denver, Colorado, United States, 80010|
|Study Chair:||Andrew S. Kraft, MD||University of Colorado, Denver|