Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1b study for safety and tolerability of bevacizumab(Avastin)administered into the tumor resection cavity in subjects with Glioblastoma Multiforme (GBM) at first recurrence.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brain & Spine Surgeons of New York
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

1. Recurrent Glioblastoma

2. At least 12 weeks expected survival (KPS >60)

3. 18 years of age or older

4. Able and willing to participate

Exclusion Criteria:

1. Any prior diagnosis of any other cancer or other concurrent malignancy.

2. Planned use or current use of other investigation therapy.

3. Systemic autoimmune disease

4. HIV positive

5. Concurrent life threatening disease

6. Impaired organ function

7. Active infection

8. Inadequately controlled hypertension

9. Congestive heart failure

10. Myocardial infection/unstable angina within 6 months

11. Stroke within 6 months

12. Pheripheral vascular disease

13. History of abdominal fistula/gastrointestinal performation

14. Non-healing wound

15. Coagulation disease

16. Known allergy to study treatments

17. Pregnant or lactating