Expired Study
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Cleveland, Ohio 44106


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00068614


Primary Contact:

Study Chair
Beth A. Overmoyer, MD, FACP
Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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