Trial | NCT01526837  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    1
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.
Study Started
Oct 31
2011
Primary Completion
Jan 31
2012
Study Completion
Jan 31
2012
Last Update
Jul 12
2017

Drug Avastin

Topical Avastin plus Collagen Sponge placed in surgical cavity after resection of recurrent brain tumor. Dosing range: 0.25 mg/ml - 25 mg/ml.

bevacizumab (Avastin) Experimental

Open-label, dose-escalating study conducted in cohorts of 1-3 patients treated at increasing doses of bevacizumab in the dose range of 1-25mg/Ml. A maximum of 24 subjects will be treated in this study (up to 8 cohorts of 3 subjects).

Criteria 

Inclusion Criteria:

Recurrent Glioblastoma
At least 12 weeks expected survival (KPS >60)
18 years of age or older
Able and willing to participate

Exclusion Criteria:

Any prior diagnosis of any other cancer or other concurrent malignancy.
Planned use or current use of other investigation therapy.
Systemic autoimmune disease
HIV positive
Concurrent life threatening disease
Impaired organ function
Active infection
Inadequately controlled hypertension
Congestive heart failure
Myocardial infection/unstable angina within 6 months
Stroke within 6 months
Pheripheral vascular disease
History of abdominal fistula/gastrointestinal performation
Non-healing wound
Coagulation disease
Known allergy to study treatments
Pregnant or lactating
No Results Posted