A Explore Study of Bevacizumab Combined With Conventional Therapy in Glioblastoma
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|ClinicalTrials.gov Identifier: NCT01939574|
Recruitment Status : Unknown
Verified January 2016 by Jinming Yu, Shandong Cancer Hospital and Institute.
Recruitment status was: Active, not recruiting
First Posted : September 11, 2013
Last Update Posted : January 21, 2016
This is a single-center, open-label, single arm study to explore whether potential image biomarkers correlate with efficacy of bevacizumab combined with conventional therapy in newly diagnosed glioblastoma.
Despite the increase in therapies available, the median survival of patients with glioblastoma multiforme (GBM) remains less than 15 months.
The phase III pivotal study in newly diagnosed GBM also met its co-primary endpoint of progression-free survival (PFS) which further confirm the efficacy of bevacizumab in GBM.
Early predicting the efficacy of bevacizumab combined with conventional therapy in newly diagnosed glioblastoma could help us to identify the suitable patients to receive suitable treatment in GBM. Thus, characterizing the blood flow and blood volume in the tumor and their changes during therapy might provide information on vasculature growth or collapse,edema formation, tumor growth, and/or cell death(necrosis) .We decided to investigate whether the estimation of blood circulation in tumor, using MRI,PET could be used as a surrogate marker to predict the early response of GBM to bevacizumab.
Several previous studies have demonstrated that the relative cerebral blood volume (rCBV) correlated with the histologic grade of gliomas and investigated the prognostic value of the tumor CBV for survival.In current study, We hypothesized that, the temporal changes during anti-angiogenesis therapy in specific regions of high and low perfusion in glioblastoma might predict the efficacy of bevacizumab.Since there is no mature PET tracer directly image Vascular Endothelial Growth Factor (VEGF) in China,we use 18F-Galacto-arginine-glycine-aspartic acid (RGD)-- a new tracer for PET imaging of αvβ3 by testing Standardized uptake value mean (SUVmean),Standardized uptake value max (SUVmax) and tumor to non-tumor tissue ratios (T/NT) to indirectly reflect the VEGF expression. The integrin αvβ3 is an important receptor affecting tumor growth, local invasiveness, and metastatic potential. Specifically, αvβ3 is highly expressed on activated endothelial cells during angiogenesis.
Therefore, in the pilot study, we use dynamic contrast enhanced magnetic resonance imaging (DCE-MRI),dynamic susceptibility-contrast magnetic resonance imaging (DSC-MRI) and 18F-Galacto-RGD PET to explore the potential image biomarkers of bevacizumab used in newly diagnosed glioblastoma.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Other: Chemoradiation Therapy Other: Adjuvant Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single Arm Study to Explore Whether Potential Image Biomarkers Correlate With Efficacy of Bevacizumab Combined With Conventional Therapy in Newly Diagnosed Glioblastoma|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||September 2016|
Experimental: Chemoradiation & Adjuvant Therapy:
Other: Chemoradiation Therapy
Other: Adjuvant Therapy
- Correlation between image biomarker change and PFS [ Time Frame: At Week 10 of the study ]
PFS (evaluated by RANO criteria), defined as the interval from start of treatment to investigator-assessed progression or death, whichever occurs first or lost of follow-up.
At Week 10 of the study (corresponding to 7 weeks after the commencement of bevacizumab therapy).
- To assess overall survival(OS) [ Time Frame: Up to 106 weeks ]OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.
- To evaluate the overall response rate (ORR) [ Time Frame: At baseline, on day 22, 70, 127, end of treatment and every 2 months of follow-up ]ORR is the number of responders (CR, PR) vs. the whole study population.Tumor response will be evaluated according to the Response Assessment in Neuro-Oncology (RANO) criteria.
- To evaluate health-related quality of life [ Time Frame: On day 1, 22, 71, end of treatment and every 2 months of follow-up ]European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30
- To assess the safety profile [ Time Frame: Up to 106 weeks ]Safety will be measured based on the NCI-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v4.0
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): NCT01939574
|Shandong Cancer Hospital and Institute|
|Jinan, Shandong, China, 250117|
|Study Chair:||Jinming Yu, PhD||Shandong Cancer Hospital and Institute|