HER-2 Protein Vaccine in Treating Women With Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I Trial Evaluating The Safety Of Intramuscular Injections Of HER-2 Protein AUTOVAC (PX104.1.6) In Patients With Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: HER-2/neu peptide vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HER-2/neu peptide vaccine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer