Glioma Patients Clinical Trial
Official title:
Hypertension Monitoring in Glioma Patients Treated With Bevacizumab
| Verified date | June 2013 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: UZurich |
| Study type | Observational |
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
| Status | Terminated |
| Enrollment | 40 |
| Est. completion date | August 2012 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Zurich, Internal Medicine | Zurich | ZH |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Hypertension | Hypertension under treatment |