Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R&D number: CO11/10054
Study information
Scientific title
REO13 Brain: A clinical study to evaluate the biological effects of preoperative intravenous administration of wild-type reovirus (REOLYSIN®) in patients prior to surgical resection of recurrent high grade primary or metastatic brain tumours.
Acronym
Study hypothesis
Intravenously injected wild-type reovirus (REOLYSIN®) can access recurrent high-grade primary or metastatic brain tumours in patients.
Ethics approval
Leeds East Ethics Committee, 04/09/2012
Study design
Open-label non-randomised interventional phase 1b clinical study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Recurrent high-grade brain tumours and metastatic brain tumours
Intervention
Patients will be allocated to one of two groups:
Group A will be patients undergoing surgery for recurrent high grade primary brain tumours who require further debulking.
Group B will be patients planned for resection of brain metastases from any known solid tumour type. Patients will be enrolled in cohorts of 3 as follows.
In each group, the first 3 patients will have a single infusion of REOLYSIN on Day 1 only (cohort 1). The next 3 will have infusions on Days 1, 2 and 3 (cohort 2), and the final cohort of 3 will receive REOLYSIN on days 1 through 5. All doses of REOLYSIN will be at 1x10^10 TCID50, administered as a 1-hour IV infusion.
Intervention type
Biological/Vaccine
Phase
Phase I
Drug names
Reolysin
Primary outcome measure
Assessment for the presence of reovirus within recurrent high grade primary or metastatic brain tumours in patients by examination of the resected surgical specimen
Secondary outcome measures
1. Assessment of the replication and antineoplastic effects of reovirus in brain tumours
2. Assessment of the safety profile of REOLYSIN before surgery for brain tumours
3. Monitoring of the humoral and cellular immune response to REOLYSIN
Overall trial start date
01/09/2012
Overall trial end date
31/08/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female subjects with a diagnosis of recurrent high grade primary or secondary brain tumour, planned for surgical management
2. Have evidence of measurable or evaluable disease on standard of care imaging
3. Have NO continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures, i.e., all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) Grade ≤1. Radiotherapy/chemotherapy/surgery (except biopsies) must have occurred at least 28 days prior to study enrolment
4. Be at least 18 years of age
5. Have completed any previous systemic chemotherapy at least 4 weeks before entry into the study
6. Have an ECOG Performance Score of ≤ 1
7. Have a life expectancy of at least 1 month
8. Have baseline laboratory results at the time of consent as follows:
8.1. Absolute neutrophil count (ANC) ≥ 1.5 x 109 [SI units 109/L]
8.2. Platelets ≥ 100 x109 [SI units 109/L] (without platelet transfusion)
8.3. Haemoglobin ≥ 9.0 g/dL [SI units gm/L] (with or without RBC transfusion)
8.4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
8.5. Bilirubin ≤ 1.5 x ULN
8.6. AST/ALT ≤ 2.5 x ULN
8.7. Negative serum pregnancy test for females of childbearing potential
9. Have signed an informed consent indicating that the patient is aware of the neoplastic nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts
10. Be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
At least 6 and up to 18
Participant exclusion criteria
1. Receive concurrent therapy with any other investigational anticancer agent while on study
2. Patients on immunosuppressive therapy other than steroids, or known HIV infection or hepatitis B or C
3. Be a pregnant or breast-feeding woman. Female patients of childbearing potential must agree to use effective contraception, must be surgically sterile, or must be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile. Barrier methods are a recommended form of contraception.
4. Have clinically significant cardiac disease (New York Heart Association, Class III or IV) including pre-existing arrhythmia, uncontrolled angina pectoris, myocardial infarction 1 year prior to study entry, or grade 2 or higher compromised left ventricular ejection fraction
5. Have dementia or altered mental status that would prohibit informed consent
6. Have 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
Recruitment start date
01/09/2012
Recruitment end date
31/08/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
c/o Clare Skinner
Joint Leeds Sponsor Office
R&D Department
34 Hyde Terrace
Leeds
LS2 9NJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Brain Tumour Research and Support across Yorkshire [BTRS] (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list