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Bryostatin 1 in Treating Patients With Stage IV Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Registration Number
NCT00003205
Lead Sponsor
University of Colorado, Denver
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Colorado Cancer Center

🇺🇸

Denver, Colorado, United States

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