ISRCTN70443973已完成1 期
REO13 Brain: A clinical study to evaluate the biological effects of preoperative intravenous administration of wild-type reovirus (REOLYSIN®) in patients prior to surgical resection of recurrent high grade primary or metastatic brain tumours.
niversity of Leeds (UK)0 个研究点目标入组 18 人开始时间: 2012年8月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female subjects with a diagnosis of recurrent high grade primary or secondary brain tumour, planned for surgical management
- •2. Have evidence of measurable or evaluable disease on standard of care imaging
- •3. Have NO continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures, i.e., all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) Grade =1. Radiotherapy/chemotherapy/surgery (except biopsies) must have occurred at least 28 days prior to study enrolment
- •4. Be at least 18 years of age
- •5. Have completed any previous systemic chemotherapy at least 4 weeks before entry into the study
- •6. Have an ECOG Performance Score of = 1
- •7. Have a life expectancy of at least 1 month
- •8. Have baseline laboratory results at the time of consent as follows:
- •8.1. Absolute neutrophil count (ANC) = 1.5 x 109 [SI units 109/L]
- •8.2. Platelets = 100 x109 [SI units 109/L] (without platelet transfusion)
- •8.3. Haemoglobin = 9.0 g/dL [SI units gm/L] (with or without RBC transfusion)
- •8.4. Serum creatinine = 1.5 x upper limit of normal (ULN)
- •8.5. Bilirubin = 1.5 x ULN
- •8.6. AST/ALT = 2.5 x ULN
- •8.7. Negative serum pregnancy test for females of childbearing potential
- •9. Have signed an informed consent indicating that the patient is aware of the neoplastic nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts
- •10. Be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests
排除标准
- •1. Receive concurrent therapy with any other investigational anticancer agent while on study
- •2. Patients on immunosuppressive therapy other than steroids, or known HIV infection or hepatitis B or C
- •3. Be a pregnant or breast-feeding woman. Female patients of childbearing potential must agree to use effective contraception, must be surgically sterile, or must be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile. Barrier methods are a recommended form of contraception.
- •4. Have clinically significant cardiac disease (New York Heart Association, Class III or IV) including pre-existing arrhythmia, uncontrolled angina pectoris, myocardial infarction 1 year prior to study entry, or grade 2 or higher compromised left ventricular ejection fraction
- •5. Have dementia or altered mental status that would prohibit informed consent
- •6. Have any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study
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