Glioblastoma Multiforme Clinical Trial
Official title:
The Effect of Radiotherapy and Temozolomide on the Tumor Vasculature and Stem Cells in Human High-grade Astrocytomas
The purpose of the current trial is to explore whether the standard treatment with 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.
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.
Secondary objectives:
- 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.
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Observational Model: Cohort, Time Perspective: Prospective
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