Glioblastoma Multiforme Clinical Trial
Official title:
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
Verified date | July 2017 |
Source | Brain & Spine Surgeons of New York |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Brain & Spine Surgeons of New York | White Plains | New York |
Lead Sponsor | Collaborator |
---|---|
Brain & Spine Surgeons of New York |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose of bevacizumab (Avastin) following local administration. | 4 weeks | ||
Secondary | Number of Adverse Events | All adverse events will be recorded in the case report form. | 12 months | |
Secondary | Progression Free Survival | Patients will be followed for survival as well as disease progression for 12 months after treatment. | 12 months |
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