Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Prof Alan Melcher


Contact details

Leeds Institute of Molecular Medicine
Wellcome Trust Brenner Building
St James’s University Hospital
United Kingdom

Additional identifiers

EudraCT number 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.


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, 4 September 2012

Study design

Open-label non-randomised interventional phase 1b clinical study

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Recurrent high-grade brain tumours and metastatic brain tumours.


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



Phase I

Drug names

Primary outcome measures

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


Overall trial end date


Reason abandoned


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Leeds Institute of Molecular Medicine
United Kingdom

Sponsor information


University of Leeds (UK)

Sponsor details

c/o Clare Skinner
Joint Leeds Sponsor Office
R&D Department
34 Hyde Terrace
United Kingdom

Sponsor type




Funder type


Funder name

Brain Tumour Research and Support across Yorkshire [BTRS] (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes