Safety, Immunology, and Biological Activity Evaluation of TroVax® in Treatment of Patients With Locally Advanced or Metastatic Renal Carcinoma
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
- Safety and tolerability of TroVax injections in conjunction with low dose IL-2
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of TroVax® investigational vaccine injections when given as first or second line treatment in conjunction with subcutaneous low dose IL-2 to patients with locally advanced or metastatic clear cell or papillary cell renal carcinoma.
TroVax® is the experimental product in this trial and its value as a medicine has not yet been proven. Interleukin-2 (IL-2) is a standard treatment for cancer, which means that it can be received even if one chooses 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 vaccines. 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 cancer cells 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 cells. 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 first or second line treatment in conjunction with subcutaneous low dose IL-2 to patients with locally advanced or metastatic clear cell or papillary cell renal carcinoma.
- To assess the immune responses induced by treatment with TroVax® and subcutaneous low dose IL-2.
Secondary:
- To assess tumour response rates, time to progression, survival and progression free survival at 6, 12 and 24 months after commencement of treatment with subcutaneous low dose IL-2.
- To assess the ability of the reintroduction of low dose subcutaneous IL-2 to induce further disease responses or stabilisation in patients being treated with TroVax® alone.
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
- •Locally advanced or metastatic, histologically proven clear cell or papillary cell renal carcinoma.
- •Primary tumour surgically removed.
- •Progressive disease
- •At least four weeks from any previous therapy for renal cancer.
- •Fit for first or second line immunotherapy with subcutaneous low dose IL-2
- •Measurable disease
- •Aged 18 years or more.
- •Patients must comply with the following:
- •Karnofsky score ≥ 80%
- •Corrected calcium ≥ 10 g/dL (2.5 mmols/L)
- •Clinically immunocompetent
- •Free of clinically apparent autoimmune disease.
- •Haemoglobin ≥ 9 g/dL, total white cell count ≥ 3 x 10^9/L and lymphocyte count ≥ 1 x 10^9/dL
- •Serum creatinine up to 1.5 times upper limit of normal.
- •Bilirubin ≤ 2 mg% and an SGPT of ≤ 4 times the upper limit of normal.
- •Able to give written informed consent and to comply with the protocol.
- •Women must be either post menopausal, or rendered surgically sterile or, if of child bearing potential, must have been practising a reliable form of contraception (oral contraception + a barrier method) for at least three months prior to the first dose of TroVax® and must continue while they are being treated with TroVax®. Men must practise a reliable form of contraception while they are being treated with TroVax®.
- •No acute changes on 12-lead electrocardiogram (ECG)
- •Ejection fraction on echocardiogram ≥ 45%
排除标准
- •Previous immunotherapy with any schedule of IL-
- •Intercurrent serious infections within the 28 days prior to entry into the trial.
- •Life threatening illness unrelated to cancer.
- •Cerebral metastases on MRI scan.
- •History of allergic response to previous vaccinia vaccinations.
- •Participation in any other clinical trial of a licensed or unlicensed drug within the previous 30 days or during the course of this trial.
- •Previous malignancies within the last 10 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.
- •Known allergy to egg proteins
- •Chronic oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency.
- •Known to test positive for HIV or hepatitis B or C
- •Known hypersensitivity to neomycin
- •Pregnancy or lactation
研究组 & 干预措施
TroVax
TroVax given as first or second line treatment in conjuntion with low dose IL-2.
干预措施: TroVax (Biological)
TroVax
TroVax given as first or second line treatment in conjuntion with low dose IL-2.
干预措施: IL-2 (Drug)
结局指标
主要结局
Safety and tolerability of TroVax injections in conjunction with low dose IL-2
时间窗: 48 weeks
To assess the safety and tolerability of TroVax injections when given as first or second line treatment in conjunction with subcutaneous low dose IL-2 to patients with locally advanced or metastatic clear cell or papillary cell renal carcinoma. To assess the immune responses induced by treatment with TroVax and subcutaneous IL-2
次要结局
- Tumour Response Rates(6, 12 & 24 months)