Pilot Study of Immunization of High Risk Breast Cancer Patients With a Sialyl Lewisª -Keyhole Limpet Hemocyanin Conjugate Plus the Immunological Adjuvant QS-21
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects and how well giving vaccine therapy together with QS21 works in treating patients with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety of sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine and QS21 immunoadjuvant in patients with metastatic breast cancer.
- Determine the IgG and IgM antibody response to this regimen in these patients.
- Determine the proportion of breast cancer cells expressing this antigen in these patients.
Secondary
- Monitor the presence of circulating tumor cells prior to, during, and after this regimen in these patients.
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:
- •Histologically confirmed stage IV breast cancer meeting 1 of the following criteria:
- •No evidence of disease
- •Stable disease on hormonal therapy
- •Stable disease must be present for ≥ 2 months and include < 30% decrease or < 20% increase in the sum of the longest diameter of target lesion
- •No new target lesions or unequivocal progression of non-target lesions
- •Elevation in the CA 153 (BR2729) or CEA values allowed
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Female or male
- •Menopausal status not specified
- •Karnofsky performance status 80-100%
- •Lymphocyte count ≥ 500/mm³
- •WBC ≥ 3,000/mm³
- •Creatinine ≤ 1.5 times upper limit of normal (ULN)
- •AST ≤ 1.5 times ULN
- •Alkaline phosphatase ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No history of allergy to seafood
- •No NYHA class III-IV cardiac disease
- •No other active cancers except basal cell or squamous cell carcinoma of the skin
- •No active infection requiring antibiotic treatment
- •No known history of immunodeficiency or autoimmune disease
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy
- •At least 4 weeks since prior radiotherapy
- •At least 4 weeks since prior surgery
- •At least 6 weeks since prior immunotherapy
- •No prior sialyl Lewisª antigen
- •No concurrent immunosuppressive medications (i.e., corticosteroids)
- •Concurrent hormonal therapy allowed
排除标准
- 未提供
研究组 & 干预措施
Vaccine Therapy and QS21
Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.
Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.
After completion of study treatment, patients are followed every 3 months
干预措施: laboratory biomarker analysis (Other)
Vaccine Therapy and QS21
Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.
Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.
After completion of study treatment, patients are followed every 3 months
干预措施: sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine (Biological)
Vaccine Therapy and QS21
Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.
Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.
After completion of study treatment, patients are followed every 3 months
干预措施: immunoenzyme technique (Other)
Vaccine Therapy and QS21
Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.
Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.
After completion of study treatment, patients are followed every 3 months
干预措施: immunologic technique (Other)
Vaccine Therapy and QS21
Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.
Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.
After completion of study treatment, patients are followed every 3 months
干预措施: QS21 (Biological)
结局指标
主要结局
Safety
时间窗: 2 years
Immune Response
时间窗: 2 years
次要结局
- Presence of Circulating Tumor Cells(2 years)