ACTRN12609000277246终止1 期
A phase I, open-label, dosage escalation, study of multiple doses of CAVATAKTM (CVA21; Coxsackievirus A21) administered intratumourally in the treatment of squamous cell carcinoma of the head and neck bearing ICAM-1 receptors
Viralytics Limited0 个研究点目标入组 9 人开始时间: 2009年5月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients who are willing and able to provide written informed consent to participate in the study. Patients with histologically confirmed metastatic or recurrent squamous cell carcinoma of the head or neck currently documented as progressive disease”. Head and neck cancer patients with at least one tumour mass where the tumour mass is accessible for intratumoural injection and can be measured at periodic intervals for tumour size using callipers and/or ultrasound. All patients to have histologically confirmed squamous cell carcinoma of the head and neck (excluding nasopharyngeal) that had recurred or relapsed after surgery and/or radiotherapy and/or chemotherapy. The longest diameter of the target injectable tumour being no greater than 6 cm or no less than 1 cm in the longest diameter.
- •The tumour mass to be intratumourally injected to be easily accessible for injection and amenable to measurement by physical examination and / or radiographically.
- •Patients to be 18 years or older
- •Absence of circulating antibodies to CVA21 (titre < 1:16).
- •Adequate haematological, hepatic and renal function, defined as:
- •ANC > 1.5 x 109/L, platelets > 100 x 109/L
- •Bilirubin < 20umol/L, AST < 2.5 times the upper limit of normal
- •Calculated creatinine clearance > 30 mL/minute
- •Adequate immunologic function, defined as:
- •Serum IgG > 5g/L
- •T cell subsets within normal limits
- •Fertile males and females must agree to the use of an adequate form of
- •contraception. Hormonal contraceptives should be supplemented with an additional barrier method. Negative pregnancy test is required in female patients of child-bearing potential.
排除标准
- •Patients receiving radiotherapy to the proposed injected tumour or radiotherapy within the last 3 weeks
- •Performance status > 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- •Life expectancy < 6 months.
- •Pregnancy or breastfeeding.
- •Primary or secondary immunodeficiency, including immunosuppressive disease, and immunosuppressive doses of corticosteroids (e.g. prednisolone > 7.5mg per day) or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks.
- •Positive serology for Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C.
- •Splenectomy.
- •Presence of uncontrolled infection.
- •Any uncontrolled medical condition that in the opinion of the Investigator is likely to place the patient at unacceptable risk during the study or reduce their ability to complete the study
- •Participation in another study requiring administration of an investigational drug or biological agent within the last 4 weeks
- •Known allergy to treatment medication or its excipients
研究者
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