Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT02120287|
Recruitment Status : Active, not recruiting
First Posted : April 22, 2014
Last Update Posted : May 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme Glioblastoma - Category||Drug: Bevacizumab Procedure: Magnetic Resonance Spectroscopy (MRS) Procedure: Border Zone Stereotactic Radiosurgery (BZ-SRS)||Phase 2|
Glioblastoma Multiforme (GBM) is the most common primary brain tumor in adults. Unfortunately, despite aggressive surgery, radiation therapy (RT) and chemotherapy, the prognosis for this disease is poor. It is our hypothesis that GBM is a "local" disease wherein treatment failure is due to failure to eradicate tumor cells in the pathways along which the tumor eventually spreads (the "border zone").
The investigators hypothesize that treatment volume escalation will be successful at improving overall survival in patients with GBM when appropriate targeting and precision dose delivery is performed in a single treatment session. The 'border zone' of the tumor will be targeted for SRS (defined as a combination of the MRI volume of gadolinium enhancement plus up to 2 cm of the surrounding T2 volume). This represents the volume of tumor infiltrated white matter and is the route of GBM spread. Bevacizumab, a monoclonal antibody to vascular endothelial growth factor (VEGF), has been used with safety and clinical success with concomitant chemotherapy in solid tumors, including GBM.
The investigators further hypothesize that a combined approach of SRS with this VEGF inhibitor will be an effective strategy for GBM because bevacizumab will maximize the effects of radiation in the treated volume and potentially reduce radiation toxicity in the adjacent brain.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Phase II Study of Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Multiforme|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: BZ-SRS with Bevacizumab
All patients will receive Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally receive bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until progression.
One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS
Patients will receive bevacizumab (10 mg/kg) one day before and then at day 14 followed by10 mg/kg/day every 14 days until progression.
Other Name: Avastin
Procedure: Magnetic Resonance Spectroscopy (MRS)
Subjects will have MRS prior to BZ-SRS.
Procedure: Border Zone Stereotactic Radiosurgery (BZ-SRS)
The 'border zone' of the tumor will be targeted by SRS in a single session.
Other Name: GammaKnife
- Overall Survival [ Time Frame: Two years ]To assess the efficacy of Border Zone SRS with bevacizumab by overall survival in patients with recurrent or progressive glioblastoma following conventional management with surgery, fractionated radiation therapy, and chemotherapy.
- Survival at 6 months [ Time Frame: Six months ]To estimate progression-free and overall survival at 6 months
- CNS Toxicity [ Time Frame: Six months after SRS ]To evaluate the CNS late toxicity of combined treatment
- Survival compared to historical outcome [ Time Frame: Two years ]To evaluate survival following border zone SRS with bevacizumab in comparison to historical outcome
- Tumor Response & Radiosurgical Toxicity [ Time Frame: Two years ]To evaluate whether border zone SRS with bevacizumab improves tumor response or reduces radiosurgical toxicity compared to historical outcomes
- Quality of Life [ Time Frame: Two years ]To evaluate the quality of life of border zone SRS with bevacizumab administration
- Magnetic Resonance Spectroscopy (MRS) [ Time Frame: Two years ]To evaluate the potential value of magnetic resonance spectroscopy (MRS) in improvement of border zone target selection and detection of therapeutic response
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): NCT02120287
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Ajay Niranjan, MD||University of Pittsburgh|