Recurrent high-grade brain tumours and metastatic brain tumours Cancer Malignant neoplasm of brain
Conditions
Interventions
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.
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed