Investigation of the immunological effect of medication in patients with brain tumors

An open label, Phase IV study to assess immunological changes in patients with glioblastoma multiforme treated with bevacizumab infusion

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002700-21-HU

Enrollment

155

Registered

2022-11-22

Start date

2023-02-28

Completion date

Unknown

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma multiforme

Interventions

Trade Name: Avastin Product Name: Avastin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Bevacizumab CAS Number: 216974-75-3 Concentration unit: mg/kg milligram(s)/kil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Glioblastoma multiforme Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Any other current tumors or known tumors in the patient's medical history .

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.Immunological changes in patients during the course of the disease before and under bevacizumab treatment, which might predict the course of the disease. 2.Local relapse free survival 3.Progression free survival 4.Overall survival. ;Secondary Objective: Investigation of plasma-derived extracellular vesicles (EV), their micro-RNA and protein content, and free DNA-RNA fragments. We do not perform genome sequencing.;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Per month	—

Measure

Time frame

Main Objective: 1.Immunological changes in patients during the course of the disease before and under bevacizumab treatment, which might predict the course of the disease. 2.Local relapse free survival 3.Progression free survival 4.Overall survival. ;Secondary Objective: Investigation of plasma-derived extracellular vesicles (EV), their micro-RNA and protein content, and free DNA-RNA fragments. We do not perform genome sequencing.;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Per month

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in selected immunological parameters, like CD45-, CD31+, CD34+, CD133-, CD146+, VEGFR1+ , CD45-, CD34Bright, CD31+, CD133+, VEGFR1, CD105, VEGFR1, VEGFR2, CD140b, VEGF2, TIE2, CD106, CD276.;Timepoint(s) of evaluation of this end point: Half a year	—

Countries

Hungary

Contacts

Public ContactNational Institute of Oncology

National Institute of Oncology

juranyi.zsolt@oncol.hu361224-8779

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026