ISRCTN71601938已完成2 期
A randomised stratified multicentre phase II clinical trial of single agent pegylated arginine deiminase (ADI-PEG 20) in patients with malignant pleural mesothelioma
Barts and The London NHS Trust (UK)0 个研究点目标入组 63 人开始时间: 2010年10月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
研究概览
简要总结
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/27584578
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females aged 18 years and older (there is no upper age limit)
- •2. Histopathological evidence of ASS-negative MPM. All biopsies will be reviewed for ASS expression using immunohistochemistry (central review by Dr Michael Sheaff, Institute of Cell and Molecular Sciences, Barts and The London School of Medicine)
- •3. Performance status Eastern Cooperative Oncology Group (ECOG) 0 - 1
- •4. No prior systemic chemotherapy
- •5. Computed tomography (CT) evaluable disease by modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria
- •6. Adequate haematological status (haemoglobin 10 g/dl or greater; white cell count 2 x 10^9/L or greater, neutrophil count 1.5 x 10^9/L or greater; platelets 100 x 10^9 /L or greater)
- •7. Adequate hepatic function (bilirubin less than 1.5 x upper limit of normal; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 x upper limit of normal)
- •8. Creatinine clearance greater than 30 ml/min
- •9. Willing to give written informed consent to participate
排除标准
- •1. Any of the above inclusion criteria are not met
- •2. Enrolment in another clinical trial
- •3. Patients with surgically resectable disease
- •4. Recurrent pleural effusion (not pleurodesed)
- •5. Receipt of extensive radiation (hemi-thorax) therapy within 6 weeks before enrolment. Radiation to chest port sites following thoracotomy is permitted.
- •6. A history of prior malignant tumour, unless the patient has been without evidence of disease for at least three years, or the tumour was a non-melanoma skin tumour or in-situ cervix carcinoma
- •7. Symptomatic or known brain or leptomeningeal metastases
- •8. Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment
- •9. New York Heart Association (NYHA) class III or IV heart failure (attachment 10, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
- •10. Serious medical (e.g. uncontrolled diabetes, hepatic disease, infection) or psychiatric illness likely to interfere with participation in this clinical study
- •11. History of seizures
- •12. Patients of child-bearing age must not become pregnant. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Acceptable birth control measures whilst on the study include barrier and hormonal methods; patients that are surgically sterile are also eligible to participate in this study.
- •13. Females must not be breastfeeding
- •14. Prior exposure to ADI-PEG 20
- •15. Pre-planned surgery or procedures that would interfere with the study protocol
- •16. Allergy to pegylated products
研究者
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