A Pilot Study Of Sequential Vaccinations With Recombinant Vaccinia-CEA(6D)-TRICOM, And Recombinant Fowlpox-CEA(6D)-TRICOM (B7.1/ICIAM-1/LFA-3) With Sargramostim (GM-CSF), In Conjunction With Standard Adjuvant Chemotherapy In High Risk Breast Cancer Patients Status Post Surgery With 4+ Or More Lymph Nodes And CEA Expressing Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with sargramostim and chemotherapy may kill more tumor cells.
PURPOSE: Randomized clinical trial to study the effectiveness of vaccine therapy plus sargramostim and combination chemotherapy in treating women who have undergone surgery for stage II or stage III breast cancer that has spread to the lymph nodes.
详细描述
OBJECTIVES:
- Compare the immunological effects of 2 different schedules of vaccinia-CEA-TRICOM vaccine, fowlpox-CEA-TRICOM vaccine, and sargramostim (GM-CSF) administered with standard adjuvant chemotherapy in women with high-risk stage II or III breast cancer.
- Compare the safety of these regimens in these patients.
- Determine the feasibility of obtaining determinations of CD4 response in patients treated with these regimens.
- Compare disease-free survival of patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
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Vaccinia-CEA-TRICOM: Beginning 2-3 weeks after surgery and before initiation of standard adjuvant chemotherapy, all patients receive vaccinia-CEA-TRICOM vaccine subcutaneously (SC) on day 1 and sargramostim (GM-CSF) SC on days 1-4 of week 1.
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Fowlpox-CEA-TRICOM: Patients are treated on 1 of the following schedules:
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Arm I: During chemotherapy, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4 of weeks 2, 5, 8, 11, 14, 17, 20, and 23. After chemotherapy, patients receive additional vaccinations on weeks 26, 38, and 50.
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Arm II: Prior to chemotherapy, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4 of week 2. After chemotherapy, patients receive additional vaccinations on weeks 26, 38, and 50.
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Chemotherapy: Patients receive doxorubicin IV over 5-7 minutes and cyclophosphamide IV over 30 minutes on day 1 of weeks 3, 6, 9, and 12. Patients then receive paclitaxel IV over 3 hours on day 1 of weeks 15, 18, 21, and 24. Treatment continues in the absence of disease progression (after at least 1 course of chemotherapy) or unacceptable toxicity.
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Radiotherapy: Patients undergo radiotherapy during weeks 26-32 in the absence of disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the breast
- •Stage II or III
- •At least 4 positive lymph nodes
- •No inflammatory ductal carcinoma
- •No positive lymph nodes by immunohistochemistry only
- •Carcinoembryonic antigen (CEA) expression, as indicated by 1 of the following:
- •At least 30% of tumor stains for CEA on immunohistochemistry
- •Elevated serum CEA (greater than 5 ng/mL) anytime during disease course
- •Must be HLA-A2 positive
- •Must have received prior vaccinia for smallpox immunization with 1 of the following as evidence:
- •If age 25 and under, physician certification of prior vaccination
- •If over age 25, patient recollection and vaccination-site scar
- •Any age, detectable anti-vaccinia antibodies
- •No metastases by CT scan of chest, abdomen, and pelvis and a bone scan
- •Hormone receptor status:
- •Estrogen receptor status and progesterone receptor status known
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT and SGPT no greater than 1.5 times ULN
- •Hepatitis B and C negative
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •No proteinuria OR
- •Protein less than 1,000 mg per 24-hour urine collection
- •No hematuria
- •No abnormal sediment
- •Cardiovascular
- •LVEF at least 45% by echocardiogram or MUGA if either of the following are true:
- •History of cardiac disease
- •Received prior cardiotoxic chemotherapy
- •Immunologic
- •No evidence of immunocompromised status
- •No autoimmune disease such as any of the following:
- •Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
- •Systemic lupus erythematosus
- •Sjogren's syndrome
- •Scleroderma
- •Myasthenia gravis
- •Goodpasture syndrome
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排除标准
- 未提供