The evaluation of safety and biological effects of cancer-killing virus vaccine given to patients with advanced brain tumours
- Conditions
- Malignant neoplasm of brain, high-grade brain tumourCancerMalignant neoplasm of brain
- Registration Number
- ISRCTN51762486
- Lead Sponsor
- niversity of Leeds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 12
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method