Back to resultsBevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
Primary Purpose
Glioblastoma Multiforme
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Avastin
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Brain tumor, GBM, Brain cancer
Eligibility 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
Sites / Locations
- Brain & Spine Surgeons of New York
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
bevacizumab (Avastin)
Arm Description
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).
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose of bevacizumab (Avastin) following local administration.
Secondary Outcome Measures
Number of Adverse Events
All adverse events will be recorded in the case report form.
Progression Free Survival
Patients will be followed for survival as well as disease progression for 12 months after treatment.
Full Information
NCT ID
NCT01526837
First Posted
November 5, 2011
Last Updated
July 11, 2017
Sponsor
Brain & Spine Surgeons of New York
1. Study Identification
Unique Protocol Identification Number
NCT01526837
Brief Title
Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Investigators decision
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brain & Spine Surgeons of New York
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
Brain tumor, GBM, Brain cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bevacizumab (Avastin)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Avastin
Intervention Description
Topical Avastin plus Collagen Sponge placed in surgical cavity after resection of recurrent brain tumor. Dosing range: 0.25 mg/ml - 25 mg/ml.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose of bevacizumab (Avastin) following local administration.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of Adverse Events
Description
All adverse events will be recorded in the case report form.
Time Frame
12 months
Title
Progression Free Survival
Description
Patients will be followed for survival as well as disease progression for 12 months after treatment.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Abrahams, MD
Organizational Affiliation
Brain & Spine Surgeons of New York
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Strack
Organizational Affiliation
BSSNY
Official's Role
Study Director
Facility Information:
Facility Name
Brain & Spine Surgeons of New York
City
White Plains
State/Province
New York
ZIP/Postal Code
10604
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
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