Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
| Status: | Terminated |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/13/2017 |
| Start Date: | October 2011 |
| End Date: | January 2012 |
A Dose-Escalating Phase I Study for Safety and Tolerability of Bevacizumab in Collagen Delivery Vehicle Administered Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
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.
the tumor resection cavity in subjects with Glioblastoma Multiforme (GBM) at first
recurrence.
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
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