Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
NCT ID: NCT01526837
Last Updated: 2017-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
1 participants
INTERVENTIONAL
2011-10-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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bevacizumab (Avastin)
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. At least 12 weeks expected survival (KPS \>60)
3. 18 years of age or older
4. Able and willing to participate
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Brain & Spine Surgeons of New York
OTHER
Responsible Party
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John Abrahams, M.D.
Associate Professor of Neurosurgery
Principal Investigators
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John Abrahams, MD
Role: PRINCIPAL_INVESTIGATOR
Brain & Spine Surgeons of New York
Jan Strack
Role: STUDY_DIRECTOR
BSSNY
Locations
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Brain & Spine Surgeons of New York
White Plains, New York, United States
Countries
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Other Identifiers
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BSSNY-B-001
Identifier Type: -
Identifier Source: org_study_id
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