her-2 protein vaccine in treating women with breast cancer

Conditions: Breast Cancer

Summary: 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.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the breast, meeting criteria for 1 of the following: * metastatic disease currently in complete or partial response or stable disease * have been receiving a stable endocrine therapy regimen (e.g., aromatase inhibitor, tamoxifen, fulvestrant, or gonadotropin-releasing hormone agonist) for at least 30 days or status post oophorectomy * completed a course of local and adjuvant systemic therapy for high-risk stage ii or iii disease (i.e., anticipated 5-year relative survival is no greater than 50%) meeting any of the following staging criteria: * stage iib with involvement of at least 4 nodes * stage iiia (t3 disease with involvement of at least 4 nodes) * any stage iiib or iiic disease * stage iv with no evidence of disease (e.g., prior resection of local chest wall recurrence with no evidence of disease elsewhere) * 1+, 2+, or 3+ her2/neu expression by immunohistochemistry * treatment with trastuzumab (herceptin®) not clinically indicated * hormone receptor status: * not specified patient characteristics: age * 18 and over sex * female menopausal status * not specified performance status * ecog 0-1 life expectancy * at least 6 months hematopoietic * platelet count at least 100,000/mm\^3 * hemoglobin at least 10 g/dl * absolute neutrophil count at least 1,500/mm\^3 hepatic * alt or ast no greater than 2.5 times upper limit of normal (uln) (5 times uln for patients with liver metastases) * bilirubin no greater than 2 mg/dl (unless due to gilbert's disease) renal * creatinine no greater than 2 mg/dl cardiovascular * no history of significant cardiovascular disease * no myocardial infarction within the past 6 months * no poorly controlled cardiac arrhythmia * no new york heart association class iii or iv heart disease * lvef at least 50% by muga other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other malignancy except basal cell skin cancer or adequately treated carcinoma in situ of the cervix * no concurrent severe autoimmune disease * no other clinically significant or serious medical disease that would preclude study participation or compromise patient safety or the results of this study prior concurrent therapy: biologic therapy * more than 4 months since prior trastuzumab * no prior anticancer vaccine therapy * no concurrent trastuzumab * no concurrent immunomodulators (e.g., thalidomide or interferons/interleukins) chemotherapy * more than 4 weeks since prior chemotherapy * no concurrent low-dose methotrexate or cyclophosphamide * no concurrent cytotoxic chemotherapy endocrine therapy * see disease characteristics * no concurrent corticosteroids * topical or inhaled steroids are allowed * no changes to current endocrine therapy regimen (e.g., discontinuation or addition of an agent) radiotherapy * more than 3 months since prior radiotherapy involving more than 25% of the bone marrow * no concurrent radiotherapy surgery * see disease characteristics * no prior bilateral breast procedures other * more than 4 weeks since prior immunosuppressive therapy * more than 30 days since prior investigational agents or clinical trial participation * no other concurrent experimental or investigational agents * no concurrent cyclosporine * no concurrent immunosuppressive agents

Keywords: stage iv breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer