A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
The goal of this clinical research study is learn if a vaccine that contains the patient's own cancer cell immunoglobulin can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). This clinical trial is a dose escalation study in which the safety of this vaccine will be studied. This is a dose escalation study in which each patient will receive vaccine at one dose level. Patients will be injected with a fragment of Deoxyribonucleic acid (DNA) containing the sequence of their own immunoglobulin gene. Patients will be required to have their diagnosis of CLL and stage confirmed prior to initiating vaccination. After vaccination patients will receive clinical and immunologic evaluation, including both humoral and cellular responses. The investigator will be assessing the patient's immune response or whether the patient's body recognizes the DNA vaccine. In addition, side effects and reactions to the vaccine will be evaluated.
详细描述
OBJECTIVES:
- To determine if patients with Binet Stage A CLL generate an immune response to an antigen delivered by a DNA vaccine.
- To determine if patients with Binet Stage A CLL generate an immune response to a tumor derived antigen delivered by a DNA vaccine.
- To determine the optimal dose of DNA vaccine to obtain anti-idiotype immune responses.
- To characterize any adverse effects of idiotypic vaccination with a DNA vaccine.
- To determine if DNA idiotypic vaccination is capable of inducing remission in Binet´s Stage A CLL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients with Binet Stage A Chronic Lymphocytic Leukemia (CLL)
- •WHO performance status of 2 or less.
- •A life expectancy of at least one year.
- •Greater than 18 years of age.
- •Availability of CLL cells which can be used for DNA extraction and processing.
- •A platelet count greater than 100 x 109/l.
- •Ability to provide full informed consent.
排除标准
- •Previous chemotherapy or radiotherapy.
- •Presence of a monoclonal band on serum electrophoresis.
- •Presence of clinically significant levels of anti-DNA antibodies, anti-muscle antibodies or rheumatoid factors or who have active autoimmune disease.
- •Presence of antibodies to human immunodeficiency virus (HIV) and known carriers of hepatitis B or hepatitis C virus.
- •Presence of other serious medical condition e.g. congestive heart failure.
- •Presence of other malignancies.
- •Pregnancy, lactation, or not using contraceptive measures.
- •Concurrent use of other anti-cancer therapy.
- •Patients allergic to tetanus vaccine.
研究组 & 干预措施
Vaccine
干预措施: CLL vaccine using DNA plasmid vector (Biological)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: Continuous reassessment up to 1 year
次要结局
未报告次要终点