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 sites12 target enrollmentJune 28, 2021

Overview

No summary available.

Registry

who.int

Start Date

June 28, 2021

End Date

July 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Leeds

•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)

•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