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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

πŸ‡ΊπŸ‡Έ

Denver, Colorado, United States

University of Colorado Cancer Center
πŸ‡ΊπŸ‡ΈDenver, Colorado, United States

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