AZD2171 in Treating Patients With Recurrent Glioblastoma Multiforme
|Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor||Drug: cediranib maleate||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of AZD2171 in Recurrent Glioblastoma|
- Proportion of patients alive and progression-free at 6 months [ Time Frame: 6 months ]
- Radiographic response proportion [ Time Frame: Up to 12 months ]Will be described with 95% confidence limits.
- Overall survival [ Time Frame: Up to 12 months ]Will be described with 95% confidence limits.
- Toxicity proportion [ Time Frame: Up to 12 months ]Will be described with 95% confidence limits.
|Study Start Date:||January 2006|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral AZD2171 once daily on days 1-28.
Drug: cediranib maleate
I. Determine the proportion of patients with recurrent glioblastoma multiforme (GM) who are alive and progression free 6 months after starting AZD2171 therapy.
I. Assess the biological effect of AZD2171 by using the following MRI techniques: dynamic contrast-enhanced imaging; arterial spin-labeling imaging; perfusion-weighted imaging; and diffusion- tensor imaging at serial time points.
II. Measure circulating endothelial and progenitor cells and plasma levels of tumstatin, (vascular endothelial growth factor (VEGF)-A and -D, sVEGF receptors, P1GF, platelet-derived growth factor (PDGF)-AA, PDGF-AB, PDGF-BB, Ang1, thrombospondin-1, and interleukin-8 as markers for response to antiangiogenic therapy in recurrent GM.
III. Correlate treatment outcomes with pre-AZD2171 tumor specimens with respect to microvascular density, basement membrane and pericyte coverage, and angiopoietin-1 and -2 expression to determine whether these immunohistochemical analyses can be predictive of the response to AZD2171.
IV. Measure polymorphisms of kdr/flk-1 gene and genetic analysis of HIF1-alpha, TP53, and endothelial nitric oxide synthase genes in the archival tumor specimens.
V. Determine the overall survival of patients with recurrent GM treated with AZD2171.
VI. Determine the radiographic response rate in patients with recurrent GM treated with AZD2171.
VII. Determine the safety of AZD2171 in this patient population.
OUTLINE: This is a multicenter study.
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305656
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Tracy Batchelor||Massachusetts General Hospital|