Clinical Trial Phase II (Single Centre Study) : A Preliminary Study of the Safety, Immunogenicity, and Clinical Efficacy of TroVax Given in Conjunction With Interleukin 2 (IL-2) in the Treatment of Stage IV Renal Cell Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- To assess immune responses induced by treatment with TroVax
研究概览
简要总结
The purpose of this study is to test the safety of an investigational vaccine called TroVax when given in conjunction with Interleukin-2 (IL-2) treatment. TroVax is the experimental product in this trial and its value as a medicine has not yet been proven. Interleukin-2 (IL-2) is standard treatment for your cancer, which means that you could receive it even if you choose not to participate in this study. TroVax is being studied as a possible treatment for patients with cancer of the kidney.
TroVax belongs to a class of medicines called a vaccine. A vaccine helps the body's immune system to recognize and kill foreign invading organisms effectively. It is believed that one of the reasons why cancer can spread through the body is that the immune system cannot recognize them as being different from normal tissues and therefore cannot kill the cancer cells. A vaccine that alerts the immune system to the presence of cancer cells in the body could lead to the immune system being able to target and kill those cancer cells effectively. This trial is of a completely new way of trying to treat cancer in the future by the use of vaccination injections. TroVax consists of a virus that has been changed so that it is no longer infectious and carries a gene for a protein called 5T4. This protein is carried by many kidney cancer calls. When the virus is injected, it makes the protein, and the body's immune system is then able to recognize this protein and kill the cells that have it (i.e. the cancer cells).
The purpose of this study is to assess the safety and tolerability of TroVax injections and to understand whether TroVax could make such an immune response happen in patients with renal cell cancer while receiving Interleukin-2 (IL-2). This study will also observe and monitor any side effects experienced in patients who receive TroVax while being treated with IL-2.
详细描述
Objectives
Primary
- To assess the safety and tolerability of TroVax injections when given as a therapeutic vaccine to patients with metastatic renal cell cancer
- To assess the immune responses induced by treatment with TroVax
Secondary
- To assess the impact of treatment with TroVax on tumour response rates, time to disease progression and two year survival.
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
- •Metastatic renal clear cell adenocarcinoma, histologically proven by biopsy of the primary tumour and/or a metastasis. If a fresh specimen is obtained for diagnostic purposes, it may be frozen and stained for 5T
- •Prior nephrectomy is not required.
- •Requiring treatment with IL-2 and able to tolerate a high dose schedule per institutional standards.
- •Aged 18 years or more.
- •Performance status (ECOG) 0 or
- •Expected survival longer than three months.
- •No clinically active autoimmune disease.
- •Total white cell count greater than or equal to 3 x 109/l.
- •Platelet count greater than or equal to 90,000/mm
- •Serum creatinine 1.6 mg/dl or less.
- •Total bilirubin 1.6 mg/dl or less.
- •Serum AST/ALT greater than or equal to three times the upper limit of normal or 5 times upper limit of normal if liver metastases are present.
- •Able to give written informed consent and to comply with the protocol.
- •Women must be either post menopausal, rendered surgically sterile or practising a reliable form of contraception (hormonal, intrauterine device or barrier). Men must practise an effective form of birth control, such as barrier protection.
- •Normal cardiac stress test if the patients are older than 50 years of age or have symptoms of cardiac disease.
- •Normal pulmonary function tests if the patient is a smoker or is known to have primary lung disease.
排除标准
- •Pregnancy, lactation or lack of effective contraception in fertile men and women of childbearing potential.
- •Intercurrent serious infections within the 28 days prior to entry to the trial.
- •Known to be HIV positive because HIV infection can lead to serious adverse events with vaccination and/or high-dose IL-
- •Life threatening illness unrelated to cancer.
- •Cerebral metastases.
- •History of allergic response to previous vaccinia vaccinations.
- •Participation in any other clinical trial within the previous 30 days .
- •Previous malignancies within the last two years other than successfully treated squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy.
- •Previous history of major psychiatric disorder requiring hospitalisation or any current psychiatric disorder that would impede the patient's ability to provide informed consent or to comply with the protocol.
- •Corticosteroids unless used as an antiemetic.
- •Family contact with active eczema, exfoliative skin disorder, pregnancy or other cause of immunocompromise.
结局指标
主要结局
To assess immune responses induced by treatment with TroVax
时间窗: duration of study
positive antibody response for the vector (MVA) / tumour (5T4)
To assess safety and tolerability of TroVax
时间窗: duration of study
incidence of adverse events, laboratory tests and occurrence of dose limiting toxicity
次要结局
未报告次要终点