The Effect of Radiotherapy and Temozolomide on the Tumor Vasculature and Stem Cells in Human High-grade Astrocytomas (Gliomstudien)
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|ClinicalTrials.gov Identifier: NCT00473408|
Recruitment Status : Terminated (Moved to another country, not possible to recruit from abroad.)
First Posted : May 15, 2007
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment|
|Anaplastic Astrocytoma Glioblastoma Multiforme Tumor Angiogenesis||Device: Functional MRI (DCE-MRI) Procedure: Blood sample Procedure: Tumor sample|
Today's standard treatment with radiotherapy and temozolomide yields a life expectancy of 1.5-3 years in patients with high-grade astrocytomas. Thus, there is a need for further therapeutic improvements in this patient population. The purpose of the current trial is to explore whether radiotherapy and temozolomide affect the tumor vasculature in patients with high-grade astrocytomas. If vascular effects are identified, future clinical trials can be proposed wherein anti-angiogenic agents are added to increase patient survival. Additionally, stem cells within malignant brain tumors is an important new area of research in this patient population, and investigations herein could contribute to identify new predictive markers and therapeutic targets.
Primary objective: To assess the vascular perfusion and permeability characteristics of high-grade astrocytomas (anaplastic astrocytoma and glioblastoma multiforme) using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in patients receiving radiotherapy and temozolomide. Furthermore to assess whether therapy-induced changes in tumor perfusion is correlated with progression-free survival.
- Analyze circulating endothelial cells in the blood by flow cytometry to explore whether these cells can be used as an indirect estimate of angiogenesis in high-grade astrocytomas
Analyze tumor specimens from patients that have had their gliomas debulked before commencing therapy
- immunostaining of the tumor vasculature to assess microvessel density
- immunostaining for tumor stem cells
- flow cytometric assessment of dissolved tumor tissue to look for tumor stem cells
- Assess progression-free survival of all patients included in the study, in order to correlate the survival data with the above tissue sampling results.
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||The Effect of Radiotherapy and Temozolomide on the Tumor Vasculature and Stem Cells in Human High-grade Astrocytomas|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||November 2011|
Device: Functional MRI (DCE-MRI)
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): NCT00473408
|Dept. of Oncology & Dept. of Radiology, Haukeland University Hospital|
|Bergen, Norway, Hordaland, Norway, 5021|
|Principal Investigator:||Hans Petter Eikesdal, MD PhD||Institute of Biomedicine, University of Bergen, Jonas Lies vei 91, 5009 Bergen, Norway|