RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of HER-2 protein vaccine in treating women who have breast cancer.
OBJECTIVES: Primary * Determine the safety of HER-2 protein AutoVac™ in women with breast cancer. Secondary * Determine the ability of this drug to bypass the tolerance to the HER-2 self-protein by raising HER-2 antibodies in these patients. * Determine the kinetics of the immune response to HER-2/neu in patients treated with this drug. OUTLINE: This is an open-label, multicenter study. Patients receive HER-2 protein AutoVac™ intramuscularly at weeks 0, 2, 6, and 10 in the absence of unacceptable toxicity. Patients are followed for up to 6 weeks. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 3 months.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Ireland Cancer Center
Cleveland, Ohio, United States
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