ISRCTN51762486进行中（未招募）1 期
A clinical study to evaluate the biological effects of preoperative intravenous administration of VCN-01 in patients prior to surgical resection of high-grade brain tumours
niversity of Leeds0 个研究点目标入组 12 人开始时间: 2021年6月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
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. Histologically confirmed recurrent grade 3 or 4 glioma, histologically confirmed recurrent grade 2 glioma with clinical/radiological evidence for high-grade transformation, or metastatic brain secondaries with previous histological confirmation of a non-central nervous system (non-CNS) primary solid malignancy
- •2. Be planned for surgical resection as per standard clinical care
- •3. Have no continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures. All such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) Grade =1. Radiotherapy, chemotherapy, or surgery (except biopsies) must have occurred at least 28 days prior to study enrolment.
- •4. Aged =16 years
- •5. Have completed any previous systemic therapy at least five half-lives of the given agent before entry into the study
- •6. Have an Eastern Cooperative Oncology Group (ECOG) Performance Score of =1
- •7. Have a life expectancy of =1 month
- •8. Have screening laboratory results as follows:
- •8.1. Absolute neutrophil count (ANC) =1.5 x 10?/l
- •8.2. Platelets =100 x10?/l (without platelet transfusion)
- •8.3. Haemoglobin =9.0 g/dl (with or without RBC transfusion)
- •8.4. Serum creatinine =1.5 x upper limit of normal (ULN)
- •8.5. Bilirubin =2.5 x ULN, unless diagnosed with Gilbert’s syndrome, in which case bilirubin =5 x ULN
- •8.6. Aspartate transaminase (AST)/alanine transaminase (ALT) ratio =2.5 x ULN
- •9. Negative serum pregnancy test for participants of childbearing potential. Women of childbearing potential are defined as those who are not surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal. Women aged <50 years would be considered postmenopausal if they have been amenorrheic for =12 months following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution. Women aged =50 years would be considered postmenopausal if they have been amenorrheic for =12 months following cessation of all exogenous hormonal treatments, had radiation-induced oophorectomy with last menses >1 year ago, had chemotherapy-induced menopause with >1 year interval since last menses, or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- •10. Participants of reproductive potential must agree to use effective contraception. Participants of childbearing potential must agree to use effective contraception and their partners must also use male condom plus spermicide throughout this period. Non-sterilized male subjects must use male condom plus spermicide with partners of childbearing potential. Appropriate contraception must be used for up to 60 days following VCN-01 infusion. Effective methods of contraception are defined as:
- •10.1. Barrier/Intrauterine Device Methods (copper T intrauterine device or levonorgestrel-releasing intrauterine system)
- •10.2. Hormonal Methods (implants, hormone shot or injection, combined pill, minipill, patch)
- •10.3. Other (sexual abstinence, bilateral tubal occlusion, vasectomised partner)
- •11. Able to provide written informed consent prior to performing any protocol-related procedures, including study-specific screening procedures
- •12. Willing and able to comply with scheduled visits, the treatment plan, laboratory tests, and additional precautions to prevent the spread of the virus
排除标准
- •1. Receive concurrent therapy with any other standard or investigational anticancer agent while on study or within 5 half-lives of the agent prior to VCN-01 infusion
- •2. Immunosuppressive therapy other than steroids, or a positive test for HIV infection or Hepatitis B or C
- •3. Positive COVID-19 Coronavirus RNA test performed according to the up-to-date LTHT SOP (COVID-19 testing for adult patients before surgery/treatment/attendance and whilst IP at LTHT”)
- •4. Pregnant or breast-feeding
- •5. Dementia or altered mental status that would prohibit informed consent
- •6. 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
- •7. Active infection or another serious illness or serious autoimmune disease
- •8. Treatment with live attenuated or mRNA vaccines within three weeks before planned VCN-01 treatment and within 2 weeks after planned VCN-01 treatment
- •9. Known chronic liver disease (such as liver cirrhosis, chronic hepatitis)
- •10. Treatment with another investigational agent within its five half-lives prior to VCN-01 infusion
- •11. Viral syndrome diagnosed during the two weeks before inclusion
- •12. In close contact with immunosuppressed patients (such as patients with chronic immunosuppressive therapy including high dose of corticosteroids, AIDS, and other chronic immune system diseases)
- •13. Li Fraumeni syndrome or previously known retinoblastoma protein (pRb) pathway deficiency
- •14. Receiving full-dose anticoagulant/antiplatelet therapy or in whom these therapies cannot be withdrawn within two days prior to the VCN-01 injection
- •15. Significant alcohol history (>70 units per week for 5 or more years)
研究者
相似试验
进行中（未招募）
1 期
A clinical study to evaluate the effect of rimantadine in patients with hepatitis C virus (HCV) infection alongside standard treatment with pegylated interferon and ribavirin.Hepatitis C Virus infection - genotype 1. Genotype 1 is least responsive to current treatment and is the focus of this study. HCV can cause severe liver damage - this study will only recruit those with no evidence of severe disease (i.e. no cirrhosis).EUCTR2011-002781-21-GBeeds Teaching Hospitals22
招募中
1 期
Clinical study on Evaluation of therapeutic effect of acupuncture on cervical spondylosis by shear wave ultrasonic elastographyCervical spondylopathyITMCTR2100004262Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital
招募中
不适用
Effect of trutyadi churna in amavata with special reference to rheumatoid arthritis.CTRI/2021/08/035463DR VISHNUPRIYA SEETHARAM
尚未招募
3 期
Ayurvedic medicine-siddartakadi yoga in depressioCTRI/2024/04/065341I
招募中
1 期
The experimental study and clinical effect evaluation of multimodal ultrasound for plantar fasciitisplantar fasciitisITMCTR2022000056Guang'anmen Hospital China Academy of Chinese Medical Science