Hypertension Monitoring in Glioma Patients Treated With Bevacizumab

This study has been terminated.
(Problems with enrollement of patients, less patients than expected)
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01046279
First received: January 8, 2010
Last updated: June 12, 2013
Last verified: June 2013

January 8, 2010
June 12, 2013
January 2010
August 2012   (final data collection date for primary outcome measure)
Incidence of Hypertension [ Time Frame: Hypertension under treatment ]
Not Provided
Complete list of historical versions of study NCT01046279 on ClinicalTrials.gov Archive Site
Not Provided
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Hypertension Monitoring in Glioma Patients Treated With Bevacizumab
Hypertension Monitoring in Glioma Patients Treated With Bevacizumab

Prospective casecontrol study in glioma patients undergoing treatment with bevacizumab (Avastin). At present there are no data on the correlation between occurrence of arterial hypertension and clinical outcome in patients with glioma or anaplastic astrocytoma. We will investigate whether glioma patients developing hypertension under bevacizumab treatment have a better outcome in terms of progression free survival, response rate and overall survival than equally treated patients remaining normotensive. Moreover, we will describe the dynamics of change in blood pressure after administration of bevacizumab in those patients developing hypertension.

  • Trial with medicinal product
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma and Urine Samples

Non-Probability Sample

Glioma patients receiving bevacizumab

Glioma Patients
Drug: Bevacizumab
Patients with histological diagnosis of anaplastic astrocytoma (WHO Grad III) or Glioma (WHO Grad IV) assigned to bevacizumab treatment (monotherapy or adjunctive to chemotherapy) for therapeutic reasons
Glioma Patient receiving Bevacizumab
Patients with histological diagnosis of anaplastic astrocytoma (WHO Grad III) or Glioma (WHO Grad IV)assigned to bevacizumab treatment (monotherapy or adjunctive to chemotherapy) for therapeutic reasons
Intervention: Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion criteria: Patients aged 18 or older with histological diagnosis of anaplastic astrocytoma (WHO grade III) or glioma (WHO grade IV) Assigned to bevacizumab treatment (monotherapy or adjunctive to chemotherapy) for therapeutic reasons by an oncologist Patients should be on a stable or decreasing dose of steroids Willingness and ability to comply with the protocol Patient should present with a KPS of >=70 Signed informed consent

Exclusion criteria: Previous anti-angiogenic drugs other than bevacizumab Allergy or hypersensitivity against bevacizumab Contraindications to bevacizumab according to the Summary of Product of Characteristics Unwillingness to comply with regular assessments of response and performance of study-related procedures Any condition considered relevant for proper performance of the study or risk to the patients, at the discretion of the investigator

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01046279
EK-1700
Yes
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Lukas Zimmerli, MD University Hospital Zurich, Internal Medicine
University of Zurich
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP