An Open, Dose-ranging, Multicenter Study to Determine the Antibody Response to G17DT and Its Safety and Tolerability in the Treatment of Patients With Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Measurable Antibody Titer
研究概览
简要总结
An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 接受健康志愿者
- 否
入选标准
- •Stage I-III Criteria-
- •Patients aged 18 years or over who had had a macroscopically curative resection for gastric adenocarcinoma.
- •Absence of metastatic disease evident from:
- •physical examination
- •the most recent chest X-ray
- •abdominal CT or ultrasound scan
- •Life expectancy of at least 3 months
- •WHO performance status of 0 to 1
- •Written informed consent given
- •Stage IV Criteria-
- •Patients aged 18 years or over with Stage IV gastric cancer: carcinoma with the primary tumour invading the adjacent structures and/or involvement of more than 15 regional lymph nodes and/or distant metastases
- •Life expectancy of at least 3 months
- •WHO performance status of 0 to 2
- •Written informed consent given
排除标准
- •History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix Recurrent gastric cancer following previous surgery Presence of metastatic disease: peritoneal deposits or involved lymph nodes outside the limit of resection
- •Previous use, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
- •Concomitant use of immunosuppressants, including systemic (ie oral or injected) corticosteroids
- •Females who were pregnant, planning to become pregnant or lactating
- •Patients who were taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study
- •Previous G17DT treatment
- •Haematological indicators:
- •Haemoglobin <10.0g/dl
- •White blood cell count <4.0 x 109/l
- •Platelets <100 x 109/l
研究组 & 干预措施
10µg, Stage I-III
10µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.
干预措施: G17DT (Drug)
100µg, Stage I-III
100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.
干预措施: G17DT (Drug)
250µg, Stage I-III
250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.
干预措施: G17DT (Drug)
100µg, Stage IV
100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.
干预措施: G17DT (Drug)
250µg, Stage IV
250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.
干预措施: G17DT (Drug)
结局指标
主要结局
Measurable Antibody Titer
时间窗: Up to Week 12
次要结局
- Injection Site Reaction(Through Week 12)
- Overall Survival from date of randomization to death or end of study(Up to Last Patient Last Visit, January 2001)