Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed GBM
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01811498|
Recruitment Status : Recruiting
First Posted : March 14, 2013
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme Brain Tumor||Drug: Bevacizumab||Phase 1 Phase 2|
The experimental aspects of this experimental plan will include:
- Subjects will first be treated with Mannitol prior to chemotherapy infusion (Mannitol 20%; delivered IA, 12.5 mL over 2 minutes) in order to disrupt the blood brain barrier. This technique has been used in several thousand subjects in previous studies for the IA delivery of chemotherapy for malignant glioma.
- Subjects will then be treated with repeated intraarterial delivery (SIACI) of Bevacizumab. Each subject will receive one dose of IA Bevacizumab on day 30, followed by chemoradiation. SIACI of Bevacizumab will be repeated every three months for a total of 3 infusions.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial of Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed Glioblastoma Multiforme|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: SIACI of Bevacizumab
Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab
Other Name: Avastin
- Composite overall response rate (CORR) [ Time Frame: 6 month ]Composite overall response rate (CORR) through the Response Assessment in Neuro-Oncology (RANO)
- Progression-free survival (PFS) and Overall survival (OS) [ Time Frame: 6-month ]OS will be measured from the date of the first dose of SIACI Bevacizumab to the date of death. A two-year follow-up time is expected to determine the safety of repeated superselective intracranial intraarterial infusions of Bevacizumab at a dose of 15 mg/kg IA.
- Toxicities [ Time Frame: 1 month ongoing ]The descriptive frequency of subjects experiencing toxicities will be tabulated.
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): NCT01811498
|Contact: John Boockvar, MDfirstname.lastname@example.org|
|Contact: Tamika Wong, MPHemail@example.com|
|United States, New York|
|Lenox Hill Brain Tumor Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: John Boockvar, MD firstname.lastname@example.org|
|Principal Investigator: John Boockvar, MD|
|Sub-Investigator: David Langer, MD|
|Sub-Investigator: Rafael Ortiz, MD|
|Sub-Investigator: Alexis Demopolous, MD|
|Sub-Investigator: Ashley Ray, NP|
|Sub-Investigator: Tamika Wong, MPH|
|Sub-Investigator: Sherese Fralin, NP|
|Principal Investigator:||John Boockvar, MD||Feinstein Institute for Medical Research|