Vaccination Of High Risk Breast Cancer Patients With Heptavalent Antigen - Keyhole Limpet Hemocyanin Conjugate Plus The Immunological Adjuvant QS21
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response and decrease the recurrence of breast cancer.
PURPOSE: Pilot trial to study the effectiveness of vaccine therapy in treating patients who are at high risk for breast cancer recurrence.
详细描述
OBJECTIVES:
- Determine whether immunization with multiple antigens comprising GM2, Globo-H, Lewis y, TF(c), sTn(c), Tn(c), and glycosylated MUC-1 32(aa) conjugated to keyhole limpet hemocyanin plus QS21 induces an antibody response against these individual antigens and breast cancer cells expressing these antigens in patients at high risk for breast cancer recurrence.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2-3 months.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of breast cancer at high risk for recurrence, defined by one of the following:
- •Stage IV that is free of all known disease after eradication by surgery, radiotherapy, or chemotherapy
- •May or may not have elevated CA 15-3 or CEA levels
- •Stage I, II, or III previously treated with adjuvant chemotherapy and clinically free of identifiable disease, but have rising CA 15-3 or CEA levels
- •Rising CA 15-3 and CEA defined as a prior normal level increased on 2 consecutive occasions at least 2 weeks apart
- •For patients with a significant history of smoking who have a chronically elevated CEA (less than 15), CEA must be increased at least 1.5 times the uppermost chronic value on 2 consecutive occasions at least 2 weeks apart
- •Stage III and completed adjuvant therapy no more than 24 months ago
- •Recurrence in the ipsilateral axilla after lumpectomy and/or axillary dissection or modified radical mastectomy
- •Recurrence in the ipsilateral breast after lumpectomy and/or axillary dissection
- •Stage II with at least 4 positive axillary nodes and completed adjuvant therapy no more than 24 months ago
- •Stage IV that is stable on hormonal therapy
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Male or female
- •Menopausal status:
- •Not specified
- •Performance status:
- •Karnofsky 80-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Lymphocyte count at least 500/mm^3
- •WBC at least 3,000/mm^3
- •AST no greater than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 1.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •No clinically significant New York Heart Association class III or IV cardiac disease
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior seafood allergy
- •No known prior immunodeficiency or autoimmune disease
- •No other active cancer except basal cell or squamous cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 6 weeks since prior immunotherapy
- •No prior vaccine with any of the antigens in this study
- •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
- 另有 4 项未显示
排除标准
- 未提供
研究组 & 干预措施
Vaccine
Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
干预措施: Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine (Biological)
Vaccine
Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
干预措施: QS21 (Biological)
结局指标
主要结局
Safety
时间窗: 2 years
By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0.
次要结局
未报告次要终点