Vaccination of High Risk Breast Cancer Patients With MUC-1 (Glycosylated) Keyhole Limpet Hemocyanin Conjugates Plus the Immunological Adjuvant QS21
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- immune response
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
详细描述
OBJECTIVES: I. Determine if immunization with glycosylated MUC-1 antigen containing MUC-1(106) or MUC-1(33) with keyhole limpet hemocyanin conjugate plus immunological adjuvant QS21 induces an antibody, helper T cell and/or cytotoxic T cell response against MUC-1 in patients with high risk breast cancer expressing MUC-1.
OUTLINE: Patients receive glycosylated MUC-1 antigen containing MUC-1(106) or MUC-1(33) with keyhole limpet hemocyanin conjugate subcutaneously (SQ) plus immunological adjuvant QS21 SQ on weeks 1-3, 7, and 19 for a total of 5 vaccinations. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS: Diagnosed breast cancer at high risk for disease recurrence with one of the following requirements: Disease free stage IV breast cancer following eradication of disease by surgery, radiotherapy, or chemotherapy Stage I, II, or III breast cancer remaining clinically free of identifiable disease following adjuvant chemotherapy with 2 consecutively rising CA15.3 (BR2729) or CEA levels at least 2 weeks apart Elevation of marker levels not needed for stage III disease if adjuvant therapy completed within past 2 years CEA increase at least 1.5 times upper chronic value in patients with significant smoking history and chronic CEA elevation less than 15 Recurrence in the ipsilateral axilla following lumpectomy/axillary dissection or modified radical mastectomy Recurrence in the ipsilateral breast following lumpectomy/axillary dissection Stage II disease with at least 4 positive axillary lymph nodes and adjuvant therapy completed within past 2 years Stable stage IV disease on hormonal therapy Colonoscopy required for isolated CEA elevation Hormone receptor status: Not specified
- •PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: Karnofsky 90-100% Life expectancy: Not specified Hematopoietic: Lymphocyte count at least 500/mm3 WBC at least 3,000/mm3 Hepatic: Alkaline phosphatase no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: No immunodeficiency or autoimmune disease No seafood allergies No other active malignancies except basal cell or squamous cell skin cancer Not pregnant Negative pregnancy test Fertile patients must use effective barrier contraception
- •PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery
排除标准
- 未提供
研究组 & 干预措施
Vaccine: MUC1-KLH vaccine/QS21
Patients receive glycosylated MUC-1 antigen containing MUC-1(106) or MUC-1(33) with keyhole limpet hemocyanin conjugate subcutaneously (SQ) plus immunological adjuvant QS21 SQ on weeks 1-3, 7, and 19 for a total of 5 vaccinations. Patients are followed every 3 months.
干预措施: MUC1-KLH vaccine/QS21 (Biological)
结局指标
主要结局
immune response
时间窗: 2 years
次要结局
未报告次要终点