The Effect of Radiotherapy and Temozolomide on the Tumor Vasculature and Stem Cells in Human High-grade Astrocytomas
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anaplastic Astrocytoma
- Sponsor
- Haukeland University Hospital
- Enrollment
- 1
- Locations
- 1
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Hans Petter Eikesdal
MD PhD
Haukeland University Hospital
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed primary high-grade astrocytoma, i.e. anaplastic astrocytoma or glioblastoma multiforme.
- •Have a WHO performance status 0-2 and be able to undergo outpatient treatment.
- •Age ≥18 years.
- •No pregnant or lactating patients can be included.
- •Patients must have radiographically documented measurable disease postoperatively. At least one tumor lesion must be unidimensionally measurable as follows:
- •Tumor lesion \> 10 mm on conventional MRI scan, T1-weighted series, after intravenous (i.v.) gadolinium chelate contrast.
- •All diagnostic radiology studies must be performed within 28 days prior to registration.
- •Absence of conditions making MRI scans impossible;
- •Cardiac pacemaker
- •Other ferromagnetic metal implants not authorised for use in MRI such as some types of cerebral aneurysm clips
Exclusion Criteria
- •Lack of fulfillment of inclusion criteria.
Outcomes
Primary Outcomes
Not specified