- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01526837
Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
July 11, 2017 updated by: John Abrahams, M.D., Brain & Spine Surgeons of New York
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
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 Overview
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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White Plains, New York, United States, 10604
- Brain & Spine Surgeons of New York
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
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Topical Avastin plus Collagen Sponge placed in surgical cavity after resection of recurrent brain tumor.
Dosing range: 0.25 mg/ml - 25 mg/ml.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Tolerated Dose of bevacizumab (Avastin) following local administration.
Time Frame: 4 weeks
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Adverse Events
Time Frame: 12 months
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All adverse events will be recorded in the case report form.
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12 months
|
Progression Free Survival
Time Frame: 12 months
|
Patients will be followed for survival as well as disease progression for 12 months after treatment.
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John Abrahams, MD, Brain & Spine Surgeons of New York
- Study Director: Jan Strack, BSSNY
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
November 5, 2011
First Submitted That Met QC Criteria
February 2, 2012
First Posted (Estimate)
February 6, 2012
Study Record Updates
Last Update Posted (Actual)
July 12, 2017
Last Update Submitted That Met QC Criteria
July 11, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Recurrence
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- BSSNY-B-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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