Spots Global Cancer Trial Database for Bryostatin 1 in Treating Patients With Stage IV Breast Cancer

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Trial Identification

Brief Title: Bryostatin 1 in Treating Patients With Stage IV Breast Cancer

Official Title: A Phase II Trial of Bryostatin-1 for the Treatment of Stage IV Breast Cancer

Study ID: NCT00003205

Conditions

Breast Cancer

Interventions

bryostatin 1

Study Description

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.

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.