Hypertension Monitoring in Glioma Patients Treated With Bevacizumab

NCT01046279 | Terminated DMC

• 1 other identifier: EK-1700
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Glioma Patients

Outcome Measures

Primary Outcomes (1)

• Incidence of Hypertension

  Hypertension under treatment

Study Arms (1)

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

Interventions

Bevacizumab DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glioma patients receiving bevacizumab

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Internal Medicine

Zurich, Canton of Zurich, 8091, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and Urine Samples

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lukas Zimmerli, MD

  University Hospital Zurich, Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 11, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 13, 2013

Record last verified: 2013-06

Locations

CH (1)