Cediranib, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00662506|
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : September 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma||Drug: Cediranib Maleate Procedure: Diffusion Tensor Imaging Procedure: Diffusion Weighted Imaging Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Radiation: Fludeoxyglucose F-18 Radiation: Intensity-Modulated Radiation Therapy Other: Laboratory Biomarker Analysis Procedure: Perfusion Magnetic Resonance Imaging Procedure: Positron Emission Tomography Drug: Temozolomide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Study of AZD2171 in Combination With Daily Temozolomide and Radiation in Patients With Newly Diagnosed Glioblastoma Not Taking Enzyme-Inducing Anti-epileptic Drugs|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Experimental: Treatment (enzyme inhibitor therapy, chemotherapy, IMRT)
See Detailed Description
Drug: Cediranib Maleate
Procedure: Diffusion Tensor Imaging
Other Name: DTI
Procedure: Diffusion Weighted Imaging
Undergo T1 weighted DCE-MRI
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Radiation: Fludeoxyglucose F-18
Undergo 18 FDG PET
Radiation: Intensity-Modulated Radiation Therapy
Other: Laboratory Biomarker Analysis
Procedure: Perfusion Magnetic Resonance Imaging
Other Name: magnetic resonance perfusion imaging
Procedure: Positron Emission Tomography
Undergo 18 F FDG-PET
- Progression-free survival (Phase II) [ Time Frame: At day 218 ]The fraction of patients alive and free of disease progression after the MRI scan scheduled. This fraction will be compared, using a one sample, two-sided exact binomial test, to 50% progression-free survival (PFS). For safety assessment, the study will be powered to ensure at least 85% chance of observing a serious adverse event, if the probability of such an event on treatment were >=5%.
- Safety profile and optimal dose of cediranib during chemoradiotherapy (Phase I) [ Time Frame: Up to 30 days after the last dose ]A dose-limiting toxicity of cediranib is defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications/temozolomide and occurs following the first dose of cediranib in the chemoradiation.
- Blood biomarkers (Phase II) [ Time Frame: Up to 1 year ]Log-transformation is expected to yield approximately homogenous and symmetric standard errors, both for Poisson events and quantities obtained by assays with successive dilutions. We will plot the median levels and quartiles over time. First, we will compare on-study values to baseline, than we will test for an association between treatment time and markers, using a linear mixed effects model with log-transformed data and a spline function of time. The two-sided, paired t-test test will be powered to detect an effect-size of 0.5.
- MRI parameters (Phase II) [ Time Frame: Up to 48 weeks ]The comparisons of all MRI measurements will be against their day -1 values (baseline), using a 2-sided, paired Wilcoxon test (Hollander and Wolfe 1973).
- Tumor biomarkers (Phase II) [ Time Frame: At baseline ]Exploratory analyses will be performed to determine if there is any correlation between the molecular/vascular phenotype of the tumor or quantitative measurements, we will use for this purpose ANOVA on log-transformed marker measurements. We will analyze changes in the measurements, and correlate biomarkers with clinical and radiographic response, similarly as for blood and urine biomarkers.
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): NCT00662506
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Tracy Batchelor||Massachusetts General Hospital|