Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
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|ClinicalTrials.gov Identifier: NCT01526837|
Recruitment Status : Terminated (Investigators decision)
First Posted : February 6, 2012
Last Update Posted : July 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Drug: Avastin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
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).
Topical Avastin plus Collagen Sponge placed in surgical cavity after resection of recurrent brain tumor. Dosing range: 0.25 mg/ml - 25 mg/ml.
- Maximum Tolerated Dose of bevacizumab (Avastin) following local administration. [ Time Frame: 4 weeks ]
- Number of Adverse Events [ Time Frame: 12 months ]All adverse events will be recorded in the case report form.
- Progression Free Survival [ Time Frame: 12 months ]Patients will be followed for survival as well as disease progression for 12 months after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01526837
|United States, New York|
|Brain & Spine Surgeons of New York|
|White Plains, New York, United States, 10604|
|Principal Investigator:||John Abrahams, MD||Brain & Spine Surgeons of New York|
|Study Director:||Jan Strack||BSSNY|