Study Stopped
Investigators decision
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
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 6, 2012
CompletedJuly 12, 2017
July 1, 2017
3 months
November 5, 2011
July 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose of bevacizumab (Avastin) following local administration.
4 weeks
Secondary Outcomes (2)
Number of Adverse Events
12 months
Progression Free Survival
12 months
Study Arms (1)
bevacizumab (Avastin)
EXPERIMENTALOpen-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).
Interventions
Topical Avastin plus Collagen Sponge placed in surgical cavity after resection of recurrent brain tumor. Dosing range: 0.25 mg/ml - 25 mg/ml.
Eligibility Criteria
You may qualify if:
- Recurrent Glioblastoma
- At least 12 weeks expected survival (KPS \>60)
- years of age or older
- Able and willing to participate
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brain & Spine Surgeons of New York
White Plains, New York, 10604, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Abrahams, MD
Brain & Spine Surgeons of New York
- STUDY DIRECTOR
Jan Strack
BSSNY
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Neurosurgery
Study Record Dates
First Submitted
November 5, 2011
First Posted
February 6, 2012
Study Start
October 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
July 12, 2017
Record last verified: 2017-07