Phase I Study of a Recombinant Fowl Pox Vaccine rF-CEA (6D)/TRICOM Alone or With GM-CSF in Patients With Advanced CEA Expressing Adenocarinomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose of recombinant fowlpox-CEA(6D)/TRICOM vaccine determined by dose-limiting toxicities graded according to NCI Common Toxicity Criteria, version 2.0
研究概览
简要总结
Phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have advanced or metastatic cancer. Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make tumor cells more sensitive to the vaccine and may kill more tumor cells
详细描述
PRIMARY OBJECTIVES:
I. Determine the toxicity of recombinant fowlpox-CEA-TRICOM vaccine with or without sargramostim (GM-CSF) or recombinant fowlpox-GM-CSF in patients with advanced or metastatic CEA-expressing adenocarcinomas.
II. Determine the CEA-specific T-cell precursor frequency in patients treated with these regimens.
III. Assess the immunogenicity of GM-CSF in patients treated with these regimens.
IV. Determine the inflammatory response and cytokine expression at the vaccination site in these patients 48 hours after vaccination.
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
- •Histologically confirmed adenocarcinoma that failed standard curative options and for which no standard palliative options are required within the next 8weeks
- •Advanced or metastatic disease
- •Recurrent or unresectable disease
- •Microscopic metastatic disease confirmed by surgical exploration allowed
- •CEA expression by immunohistochemistry
- •Circulating CEA greater than 5 ng/mL
- •HLA phenotyping required
- •HLA phenotyping must be repeated for patients who have undergone allogeneic bone marrow transplantation
- •No clinically symptomatic brain metastases
- •Patients with brain metastases who have completed palliative radiotherapy and have discontinued steroids are eligible
- •Hormone receptor status:
- •Not specified
- •Male or female
- •Performance status - ECOG 0-1
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •AST and ALT less than 3 times ULN
- •PT and PTT less than 1.5 times ULN (unless therapeutically anticoagulated)
- •Creatinine less than 1.5 mg/dL
- •Creatinine clearance greater than 60 mL/min
- •Proteinuria or hematuria less than +2 on urinalysis*
- •Urine protein less than 1,000 mg/24-hour collection, if proteinuria greater than +1
- •No frequent vomiting or severe anorexia
- •No more than 10% weight loss within the past 3 months
- •No inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis
- •No uncontrolled seizure disorders
- •No encephalitis
- •No multiple sclerosis
- •No allergy to eggs
- •No HIV-associated opportunistic infection
- •No autoimmune diseases, including the following:
- •Systemic lupus erythematosus
- •Sjögren's syndrome
- •Scleroderma
- •Myasthenia gravis
- •Goodpasture syndrome
- •Addison's disease
- •Hashimoto's thyroiditis
- •Graves' disease
- •Antinuclear antibody positive status allowed if no evidence of an autoimmune disease
- •No direct contact of vaccination site with the following persons for at least 72 hours after each vaccination:
- •Children under 1 year of age
- •Pregnant women
- •Individuals with eczema or other open skin condition
- •Immunocompromised individuals
- •No other concurrent serious medical illness that would preclude study entry
- •No other malignancy within the past 2 years except excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •Not pregnant or nursing
- •Negative pregnancy test
- 另有 21 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of recombinant fowlpox-CEA(6D)/TRICOM vaccine determined by dose-limiting toxicities graded according to NCI Common Toxicity Criteria, version 2.0
时间窗: 56 days
次要结局
未报告次要终点