Hypertension Monitoring in Glioma Patients Treated With Bevacizumab
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Purpose
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 | Intervention |
|---|---|
|
Glioma Patients |
Drug: Bevacizumab |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Hypertension Monitoring in Glioma Patients Treated With Bevacizumab |
Plasma and Urine Samples
| Estimated Enrollment: | 84 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2012 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Glioma patients receiving bevacizumab
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| Contact: 01 Studienregister MasterAdmins | +41 (0)44 255 11 11 |
| Switzerland | |
| Recruiting | |
| Zurich, Switzerland | |
| Study Director: | 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich |
More Information
No publications provided
| Responsible Party: | Lukas Zimmerli, University Hospital Zurich |
| ClinicalTrials.gov Identifier: | NCT01046279 History of Changes |
| Other Study ID Numbers: | EK-1700 |
| Study First Received: | January 8, 2010 |
| Last Updated: | August 13, 2010 |
| Health Authority: | Switzerland: UZurich |
Additional relevant MeSH terms:
|
Glioma Hypertension Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Vascular Diseases |
Cardiovascular Diseases Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013