Bryostatin 1 in Treating Patients With Stage IV Breast Cancer
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Trial of Bryostatin-1 for the Treatment of Stage IV Breast Cancer|
|Study Start Date:||April 1998|
|Study Completion Date:||April 2004|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003205
|United States, Colorado|
|University of Colorado Cancer Center|
|Denver, Colorado, United States, 80010|
|Study Chair:||Andrew S. Kraft, MD||University of Colorado, Denver|