NCT00012246终止2 期
A Trial Of Vaccination With The Carcinoembryonic Antigen (CEA) Peptide Cap 1-6D With Montanide ISA 51 Adjuvant Or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) In HLA-A2+ Patients With CEA Producing Adenocarcinomas Of Gastrointestinal (GI) Tract Origin
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Production of cytotoxic T cells
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different vaccines in treating patients who have cancer of the gastrointestinal tract.
详细描述
OBJECTIVES:
- Determine whether immunization with carcinoembryonic antigen (CEA) peptide 1-6D (CAP 1-6D) emulsified in Montanide ISA-51 adjuvant or dissolved in sargramostim (GM-CSF) can generate CAP 1-6D-specific T cells in patients with CEA-producing adenocarcinomas of gastrointestinal tract origin.
- Determine whether vaccination with CAP 1-6D can generate cytotoxic T cells against CEA-expressing tumors in these patients.
- Determine whether this vaccine can produce antitumor responses in these patients.
- Determine the frequency and severity of toxic effects associated with this vaccine in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive carcinoembryonic antigen peptide 1-6D (CAP 1-6D) emulsified in Montanide ISA-51 adjuvant subcutaneously on day 1.
- Arm II: Patients receive CAP 1-6D dissolved in sargramostim (GM-CSF) intradermally on day 1.
Treatment repeats in both arms every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage II, III, or IV adenocarcinoma of the gastrointestinal tract originating in 1 of the following:
- •Esophagus
- •Small intestine
- •Colon or rectum
- •Gall bladder
- •Extrahepatic bile ducts
- •Ampulla of Vater
- •Completed standard therapy and at risk of recurrent disease OR has relatively stable metastatic disease and a life expectancy of at least 6 months
- •Carcinoembryonic antigen (CEA)-producing tumor as evidenced by detectable blood levels of CEA or positive for CEA on immunohistochemical staining
- •Human Leukocyte Antigen (HLA)-A2+
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Southwest Oncology Group (SWOG) 0-1
- •Life expectancy:
- •See Disease Characteristics
- •Hematopoietic:
- •White Blood Count (WBC) at least 4,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 8 g/dL
- •Serum Glutamic Oxalacetic Transaminase (SGOT) or Serum Glutamic Pyruvic Transaminase (SGPT) no greater than 3 times upper limit of normal
- •Hepatitis B and C negative
- •Creatinine no greater than 2.0 mg/dL
- •No other prior malignancy unless currently disease free and off all therapy for that malignancy
- •Early skin cancer allowed
- •HIV negative
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 30 days after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •At least 4 weeks since prior surgery
- •No other concurrent therapy for malignancy
排除标准
- 未提供
结局指标
主要结局
Production of cytotoxic T cells
Antitumor response
Production of CAP 1-6D T cells
Frequency and severity of toxic effects
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
1 期
Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV MelanomaMelanoma (Skin)NCT00010309Genzyme, a Sanofi Company
已完成
2 期
PSA Vaccine Therapy in Treating Patients With Advanced Prostate CancerProstate CancerNCT00003871Eastern Cooperative Oncology Group60
Unknown
2 期
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With SurgeryMelanoma (Skin)NCT00086866European Organisation for Research and Treatment of Cancer - EORTC165
Unknown
2 期
Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal CancerColorectal CancerNCT00027833Herbert Irving Comprehensive Cancer Center
已完成
1 期
Vaccine Therapy in Treating Patients With Stage IV MelanomaMelanoma (Skin)NCT00023647Mannkind Corporation26