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Sponsors and Collaborators: |
Haukeland University Hospital University of Bergen |
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Information provided by: | Haukeland University Hospital |
ClinicalTrials.gov Identifier: | NCT00473408 |
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.
Condition | Intervention |
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Anaplastic Astrocytoma Glioblastoma Multiforme Tumor Angiogenesis |
Device: Functional MRI (DCE-MRI) Procedure: Blood sample Procedure: Tumor sample |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | The Effect of Radiotherapy and Temozolomide on the Tumor Vasculature and Stem Cells in Human High-Grade Astrocytomas |
Estimated Enrollment: | 20 |
Study Start Date: | March 2007 |
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 tumor specimens from patients that have had their gliomas debulked before commencing therapy
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have radiographically documented measurable disease postoperatively. At least one tumor lesion must be unidimensionally measurable as follows:
Absence of conditions making MRI scans impossible;
Minimum required laboratory data:
Hematology:
Biochemistry:
Exclusion Criteria:
Contact: Hans Petter Eikesdal, MD PhD | 92051962 ext 0047 | hans_eikesdal@hotmail.com |
Contact: Anne Kristine Lehmann, MD PhD | 55972010 ext 0047 | anne.kristine.lehmann@helse-bergen.no |
Norway, Hordaland | |
Dept. of Oncology & Dept. of Radiology, Haukeland University Hospital | Recruiting |
Bergen, Norway, Hordaland, Norway, 5021 | |
Contact: Hans Petter Eikesdal, MD PhD 0047 92051962 hans_eikesdal@hotmail.com | |
Contact: Anne Kristine Lehmann, MD PhD 0047 55972010 anne.kristine.lehmann@helse-bergen.no | |
Principal Investigator: Hans Petter Eikesdal, MD PhD | |
Sub-Investigator: Anne Kristine Lehmann, MD PhD | |
Sub-Investigator: Renate Grüner, PhD | |
Sub-Investigator: Torfinn Taxt, MD PhD | |
Sub-Investigator: Per Øyvind Enger, MD PhD | |
Sub-Investigator: Cecilie B Rygh | |
Sub-Investigator: Narve Brekkå | |
Sub-Investigator: Gunnar Moen, MD |
Principal Investigator: | Hans Petter Eikesdal, MD PhD | Institute of Biomedicine, University of Bergen, Jonas Lies vei 91, 5009 Bergen, Norway |
Responsible Party: | Haukeland University Hospital ( Hans Petter Eikesdal, MD PhD ) |
Study ID Numbers: | 15437, REK ID: 202.06 |
Study First Received: | May 14, 2007 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00473408 |
Health Authority: | Norway: Norwegian Social Science Data Services; Norway: Directorate for Health and Social Affairs |
Glioma DCE-MRI Angiogenesis Cancer stem cells Tumor vasculature |
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Temozolomide Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Pharmacologic Actions |