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Hypertension Monitoring in Glioma Patients Treated With Bevacizumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01046279
Recruitment Status : Terminated (Problems with enrollement of patients, less patients than expected)
First Posted : January 11, 2010
Last Update Posted : June 13, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

Condition or disease Intervention/treatment
Glioma Patients Drug: Bevacizumab

Study Design

Study Type : Observational
Actual Enrollment : 40 participants
Time Perspective: Prospective
Official Title: Hypertension Monitoring in Glioma Patients Treated With Bevacizumab
Study Start Date : January 2010
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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
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


Outcome Measures

Primary Outcome Measures :
  1. Incidence of Hypertension [ Time Frame: Hypertension under treatment ]

Biospecimen Retention:   Samples Without DNA
Plasma and Urine Samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Glioma patients receiving bevacizumab
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046279


Locations
Switzerland
University Hospital Zurich, Internal Medicine
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Lukas Zimmerli, MD University Hospital Zurich, Internal Medicine
More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01046279     History of Changes
Other Study ID Numbers: EK-1700
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Hypertension
Glioma
Vascular Diseases
Cardiovascular Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents