Avastin Plus Radiotherapy in Elderly Patients With Glioblastoma

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the efficacy of bevacizumab combined with radiotherapy compared with radiotherapy alone in the treatment of newly diagnosed glioblastoma in the elderly.

• Trial with medicinal product

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Bevacizumab

Criteria

Inclusion criteria: Diagnosis: newly diagnosed glioblastoma in elderly patients

1. Signed informed consent

2. Age > 65 years

3. Newly diagnosed supratentorial glioblastoma

4. Eligible for first infusion of bevacizumab > 28 and > 49 days after surgery for glioblastoma

5. Karnofsky performance score 60 or more

6. Paraffin-embedded tissue for central pathology review

7. Stable or decreasing corticosteroid dose within 5 days prior to enrolment

8. Adequate haematological function:

9. Adequate liver function

10. Adequate renal function

Exclusion criteria:

1. Karnofsky performance score 50 or less

2. Evidence of recent hemorrhage on postoperative brain MRI

3. Tumor with infiltration of retina, optic nerve, optic chiasm or brainstem

4. Any prior chemotherapy including carmustine-containing wafers (Gliadel®) or immunotherapy for glioblastoma or lower grade astrocytomas

5. Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential overlap in the radiation field

6. Inadequately controlled hypertension

7. History of hypertensive crisis or hypertensive encephalopathy

8. New York Heart Association (NYHA) grade II or higher congestive heart failure

9. Myocardial infarction or unstable angina within 6 months prior to enrolment

10. Stroke or transitory ischemic attack within 6 months prior to enrolment

11. Other significant vascular disease within 6 months prior to enrolment

12. History of = grade 2 haemoptysis within 1 month prior to enrolment

13. Bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation

14. Major surgical procedure, open biopsy, intracranial biopsy, ventriculoperitoneal shunt or significant traumatic injury within 28 days prior to first dose of bevacizumab

15. Core biopsy (excluding intracranial biopsy) or other minor surgical procedure within 7 days prior to first dose of bevacizumab

16. Abdominal fistula or gastrointestinal perforation within 6 months prior to enrolment

17. Intracranial abscess within 6 months prior to enrolment

18. Serious non-healing wound, active ulcer or untreated bone fracture

19. Pregnancy or lactation

20. Fertile women < 2 years after last menstruation and men unwilling or unable to use effective means of contraception

21. Active malignancy that may interfere with the study treatment at the investigator?s and PI discretion