Glioblastoma Multiforme
Conditions
Keywords
Brain tumor, GBM, Brain cancer
Brief 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.
Interventions
DRUGAvastin
Topical Avastin plus Collagen Sponge placed in surgical cavity after resection of recurrent brain tumor. Dosing range: 0.25 mg/ml - 25 mg/ml.
Sponsors
Brain & Spine Surgeons of New York
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose of bevacizumab (Avastin) following local administration. | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | 12 months | All adverse events will be recorded in the case report form. |
| Progression Free Survival | 12 months | Patients will be followed for survival as well as disease progression for 12 months after treatment. |
Countries
United States
Outcome results
None listed