Pilot Phase II Study of Safety and Immunogenicity of an ALVAC-CEA/B7.1 Vaccine Administered With Chemotherapy, Alone or in Combination With Tetanus Toxoid, as Compared to Chemotherapy Alone, in Patients With Metastatic Colorectal Adenocarcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 26
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Tetanus toxoid may make tumor cells more sensitive to chemotherapy and vaccine therapy.
PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy and vaccine therapy with or without tetanus toxoid compared with chemotherapy alone in treating patients who have metastatic colorectal cancer.
详细描述
OBJECTIVES:
- Determine the safety of ALVAC-CEA-B7.1 vaccine and chemotherapy, with or without tetanus toxoid, vs chemotherapy alone in patients with metastatic colorectal adenocarcinoma.
- Determine whether tetanus toxoid enhances the immune response in patients treated with the vaccine and chemotherapy.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive a priming dose of tetanus toxoid. Beginning 2 weeks later, patients receive tetanus toxoid and ALVAC-CEA-B7.1 vaccine subcutaneously (SC) once weekly for 3 weeks.
Two weeks after the third vaccine administration, patients receive tetanus toxoid and ALVAC-CEA-B7.1 vaccine SC on day 1 and irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 4 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
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic colorectal adenocarcinoma
- •No clinically active CNS metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 6 months
- •Hematopoietic:
- •Lymphocyte count at least 1,000/mm^3
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •AST/ALT less than 3 times ULN (5 times ULN if liver metastases present)
- •Alkaline phosphatase less than 3 times ULN (5 times ULN if liver metastases present)
- •No hepatocellular dysfunction
- •No cirrhosis
- •Creatinine less than 2.5 mg/dL
- •Cardiovascular:
- •No uncontrolled coronary artery disease
- •No symptomatic congestive heart failure
- •No uncontrolled chronic obstructive lung disease
- •Gastrointestinal:
- •No unsolved bowel obstruction or subobstruction
- •No uncontrolled Crohn's disease
- •No ulcerative colitis
- •No concurrent chronic diarrhea
- •Immunologic:
- •HIV negative
- •No immunocompromised patients
- •No diagnosis of altered immune function, including:
- •Lupus erythematosus
- •Sjogren's syndrome
- •Scleroderma
- •Myasthenia gravis
- •Goodpasture's disease
- •Addison's disease
- •Hashimoto's thyroiditis
- •Active Graves' disease
- •No known allergy to egg products or neomycin
- •No prior adverse reaction to tetanus toxoid-containing vaccines
- •No significant comorbid medical function
- •No uncontrolled infection
- •No unstable diabetes mellitus
- •No uncontrolled thyroid function abnormalities
- •No other malignancy within the past 5 years except basal cell carcinoma or adequately treated carcinoma in situ of the cervix
- •No other medical illness or mental status that would preclude study participation
- •No prior severe toxicity to adjuvant chemotherapy
- •Not pregnant or nursing
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排除标准
- 未提供