ISRCTN54669986已完成1 期
A pilot study to assess the effect of regulatory T cell depletion on 5T4-containing MVA (TROVAX®) vaccination in patients with INOPERABLE metastatic colorectal cancer
Cardiff University (UK)0 个研究点目标入组 52 人开始时间: 2011年4月5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
- 52
研究概览
简要总结
2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28880972 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patient able to give informed consent personally or through a legal representative
- •2. Signed and dated written informed consent
- •3. Aged greater than or equal to 18 years, either sex
- •4. Clinical diagnosis of inoperable colorectal cancer
- •5. World Health Organization (WHO) performance status 0 - 2
- •6. Responding or stable disease as defined by oncologist following 12 weeks of chemotherapy as demonstrated on computed tomography (CT) scan in comparison with pre-treatment CT scan (Response Evaluation Criteria in Solid Tumours [RECIST])
- •7. Subject is clinically immunocompetent
- •8. Any cancer related symptoms are under control with standard non-chemotherapy medications
- •9. Subject has adequate bone marrow function as defined by an absolute lymphocyte count greater than or equal to 500/µL, absolute neutrophil count greater than 1200/µL and platelet count greater than 100,000/µL
排除标准
- •1. Patient unable to give informed consent personally or through a legal representative
- •2. Creatinine level greater than 1.5 x upper limit of normal (ULN)
- •3. Bilirubin level greater than 50 µmol/l
- •4. Alkaline phosphatase greater than 3 x ULN
- •5. Aspartate aminotransferase (AST) and alanine aminotransferase ALT) greater than 2 x ULN
- •6. Prothrombin time greater than 18 seconds
- •7. Prior exposure to TroVax®
- •8. Life expectancy of less than 3 months
- •9. Diagnosed as being immunosupressed, receiving oral steroids (nasal sprays and inhalers are permitted) or receiving immunosuppressive therapy for oncology disorders, or following transplant
- •10. Patient has completed chemotherapy more than 2 weeks from the start of the treatment
- •11. Subject has clinically apparent/active autoimmune disease (prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, insulin dependent diabetes mellitus and rheumatoid arthritis). Note: subjects with non-insulin dependent diabetes mellitus can be included, as can subjects with controlled and rarely flaring rheumatoid disease.
- •12. Subject has a platelet count prior to start of chemotherapy greater than 400,000/µL; monocytes greater than 80,000/ µL; haemoglobin less than 9 g/dL
- •13. Significant cancer related symptoms requiring immediate treatment with chemotherapy
- •14. Currently active second malignancy, other than non-melanoma skin cancer. Subjects are not considered to have a currently active malignancy if they have completed therapy more than 5 years previously and have no known evidence of residual or recurrent disease.
- •15. Evidence of significant clinical disorder or laboratory finding which in the opinion of the investigating physician makes it undesirable for the patient to participate in the trial. No participant should have a serious or uncontrolled intercurrent infection (including those positive for HIV).
- •16. Psychiatric illnesses/social situations that limit compliance with protocol requirements
- •17. Allergy to egg proteins, cyclophosphamide, neomycin or allergic response to vaccinia vaccines
- •18. Known cerebral metastases (known from previous investigations or clinically detectable)
- •19. Haemorrhagic cystitis
- •20. Severe infection
研究者
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