A Phase 2 Study of GI-6207 in Patients With Recurrent Medullary Thyroid Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Calcitonin Growth Rate
研究概览
简要总结
Background:
- GI-6207 is an experimental cancer vaccine made with baker's yeast. The yeast has been modified to help the immune system target a protein called CEA. CEA is found on the surface of some kinds of tumor cells, including thyroid cancer cells. Researchers want to see if GI-6207 can encourage the body's immune system to attack and kill tumor cells that contain the CEA protein. They will test to see whether this vaccine is a safe and effective treatment for medullary thyroid cancer that has not responded to earlier treatments.
Objectives:
- To test the safety and effectiveness of the GI-6207 vaccine for advanced medullary thyroid cancer.
Eligibility:
- Individuals at least 18 years of age who have medullary thyroid cancer that has not responded to earlier treatments.
Design:
- Participants will be screened with a physical exam and medical history. They will provide blood and tumor samples and have an imaging study of the neck and chest. They will also have a skin test to make sure that they are not allergic to the yeast in the vaccine.
- Participants will be divided into two groups. One group will start to take GI-6207 immediately for 1 year. The second group will have 6 months of monitoring and tests with no vaccine, and then will take GI-6207 for 1 year.
- GI-6207 will be given every other week for the first seven visits (about 3 months), and then monthly for the remaining year of treatment. It will be given as injections beneath the arm and in the upper thigh. These locations will help the vaccine enter the lymph nodes and reach the immune system more quickly.
- Participants will be monitored with frequent blood and urine tests and imaging studies.
- Participants will have regular follow-up visits after their year of study vaccines.
详细描述
BACKGROUND:
- CEA is overexpressed in multiple malignancies, including medullary thyroid cancer where CEA is universally expressed on tumor cells.
- There is no standard treatment for patients with asymptomatic or minimally symptomatic, metastatic medullary thyroid cancer. The only effective FDA-approved therapy (vandetanib) comes with significant toxicity, so it is not used until patients have symptomatic or rapidly progressing disease.
- Preclinical studies have shown that GI-6207 can induce a strong immune response to CEA as well as therapeutic anti-tumor responses.
- A previous Phase I GI-6207 study has demonstrated safety and enhanced immune response in some patients.
- Preliminary data suggests that tumor growth rates can be calculated in medullary thyroid cancer patients within 3 months
- Retrospective data from prostate cancer studies suggest that vaccines can alter tumor growth rates within 3-4 months
OBJECTIVES:
Primary:
-To determine the effect of GI-6207 on calcitonin growth rate kinetics after 6 months of therapy in patients with medullary thyroid cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Calcitonin Growth Rate
时间窗: after 6 months of therapy
NCI developed an equation based on the assumption that the change of a tumor's quantity during therapy results from 2 independent component processes: an exponential (first-order kinetics) decrease/regression and an exponential regrowth of the tumor. The equation is f(t) = exp(-d\*t)+exp(g\*t) (A) where exp is the base of the natural logarithm, and f(t) is the MTC calcitonin measurement at time t in days, divided by the tumor measurement at day 0, the time at which treatment is commenced. Rate decay constant d (days\^(-1) )represents the exponential decrease of the tumor marker signal during therapy. Rate growth constant g (days-\^(1) )represents the exponential growth of the tumor during treatment. For each patient an attempt to fit Equation (A) to each data set for which more than one data point is available. Linear regressions to evaluate the relationship between the growth rate constant,g, or other parameters will be implemented using the polynomial linear routine of Sigmaplot 9.0.
次要结局
未报告次要终点