The Effect of Radiotherapy and Temozolomide on the Tumor Vasculature and Stem Cells in Human High-grade Astrocytomas
NCT ID: NCT00473408
Last Updated: 2016-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1 participants
OBSERVATIONAL
2007-03-31
2011-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Functional MRI (DCE-MRI)
MRI examination with i.v. gadolinium contrast to assess blood perfusion in remaining tumor tissue.
Blood sample
See protocol.
Tumor sample
See protocol.
Eligibility Criteria
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Inclusion Criteria
* 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
* Serious claustrophobia
* Obesity (\> 300 lb., 140 Kg)
* Patients who are receiving corticosteroids have to receive stable or decreasing doses for at least 14 days before entering the trial.
* No prior chemotherapy for high-grade astrocytoma
* Absence of opportunistic infections making temozolomide contraindicated.
* Minimum required laboratory data:
* Hematology:
* Absolute granulocytes \> 1.0 x 10\^9/L
* Platelets \> 100 x 10\^9/L
* Biochemistry:
* Bilirubin \< 1.5 x upper normal limit
* INR \< 1.5
* Serum creatinine \<1.5 x upper normal limit
* Adequate cognitive function in order to give informed consent.
* Absence of any psychological, familial or sociological condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* Before patient registration/randomization, written informed consent must be given according to national and local regulations.
18 Years
ALL
No
Sponsors
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University of Bergen
OTHER
Haukeland University Hospital
OTHER
Responsible Party
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Hans Petter Eikesdal
MD PhD
Principal Investigators
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Hans Petter Eikesdal, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Biomedicine, University of Bergen, Jonas Lies vei 91, 5009 Bergen, Norway
Locations
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Dept. of Oncology & Dept. of Radiology, Haukeland University Hospital
Bergen, Norway, Hordaland, Norway
Countries
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References
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Cao Y, Sundgren PC, Tsien CI, Chenevert TT, Junck L. Physiologic and metabolic magnetic resonance imaging in gliomas. J Clin Oncol. 2006 Mar 10;24(8):1228-35. doi: 10.1200/JCO.2005.04.7233.
Morgan B, Thomas AL, Drevs J, Hennig J, Buchert M, Jivan A, Horsfield MA, Mross K, Ball HA, Lee L, Mietlowski W, Fuxuis S, Unger C, O'Byrne K, Henry A, Cherryman GR, Laurent D, Dugan M, Marme D, Steward WP. Dynamic contrast-enhanced magnetic resonance imaging as a biomarker for the pharmacological response of PTK787/ZK 222584, an inhibitor of the vascular endothelial growth factor receptor tyrosine kinases, in patients with advanced colorectal cancer and liver metastases: results from two phase I studies. J Clin Oncol. 2003 Nov 1;21(21):3955-64. doi: 10.1200/JCO.2003.08.092. Epub 2003 Sep 29.
Mancuso P, Rabascio C, Bertolini F. Strategies to investigate circulating endothelial cells in cancer. Pathophysiol Haemost Thromb. 2003 Sep-2004 Dec;33(5-6):503-6. doi: 10.1159/000083853.
Singh SK, Hawkins C, Clarke ID, Squire JA, Bayani J, Hide T, Henkelman RM, Cusimano MD, Dirks PB. Identification of human brain tumour initiating cells. Nature. 2004 Nov 18;432(7015):396-401. doi: 10.1038/nature03128.
Other Identifiers
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REK ID: 202.06
Identifier Type: REGISTRY
Identifier Source: secondary_id
15437
Identifier Type: -
Identifier Source: org_study_id