Evaluation of the Immunogenicity of Vaccination With HER-2/Neu and CEA Derived Synthetic Peptides With GM-CSF-in-Adjuvant, in Patients With Stage IIB, III, or IV Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Safety of the 4-peptide mixture
研究概览
简要总结
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.
PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients with stage IIB, stage III, or stage IV colorectal cancer.
详细描述
OBJECTIVES:
- Determine whether vaccination comprising HER-2-neu and carcinoembryonic antigen synthetic peptides, sargramostim (GM-CSF), and Montanide ISA-51 causes an immune response in patients with stage IIB, III, or IV colorectal cancer.
- Determine the safety of this regimen in these patients.
OUTLINE: Patients receive vaccination comprising HER-2-neu and carcinoembryonic antigen synthetic peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, and 15. On day 22, patients undergo removal of the lymph node into which the vaccination site drains to determine whether the immune system is responding to the vaccine.
PROJECTED ACCRUAL: A maximum of 15 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of colorectal cancer
- •Stage IIB, III, or IV disease
- •HLA-A2- or -A3-positive
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,000/mm^3
- •Hemoglobin > 9 g/dL
- •Platelet count > 100,000/mm^3
- •Liver function tests ≤ 2.5 times upper limit of normal (ULN)
- •Creatinine ≤ 1.5 times ULN
- •Cardiovascular
- •No New York Heart Association class III or IV heart disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known or suspected allergies to any component of the study drug
- •No active connective tissue disease requiring medications
- •No systemic autoimmune disease with visceral involvement
- •No uncontrolled diabetes
- •No other severe autoimmune disease
- •No medical contraindication or potential problem that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 30 days since prior immunotherapy
- •More than 30 days since prior growth factors
- •More than 30 days since prior allergy shots
- •No prior vaccination with any study peptides for malignancy
- •Chemotherapy
- •More than 30 days since prior chemotherapy
- •Endocrine therapy
- •More than 30 days since prior steroids
- •Radiotherapy
- •More than 30 days since prior radiotherapy
- •More than 30 days since prior surgery
- •At least 30 days, but ≤ 24 months, since prior therapy for colorectal cancer
- •No concurrent illegal drug use
排除标准
- 未提供
研究组 & 干预措施
Peptide Vaccine + Montanide + GM-CSF
Colon peptide mixture (100 mcg each of the 4 peptides) plus 190 mcg of tetanus toxoid peptide, plus GM-CSF (110 mcg) in Montanide ISA-51 adjuvant
干预措施: HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine (Biological)
结局指标
主要结局
Safety of the 4-peptide mixture
时间窗: 30 days following last vaccine
Adverse events
Number of patients with an immune response to the peptides
时间窗: through Day 22
T cell responses against the peptides as measured in the sentinel immunized node
次要结局
- Immunogenicity of the peptide mixture measured in the peripheral blood(through Day 22)
研究者
Craig L Slingluff, Jr
Director, Human Immune Therapy Center
University of Virginia