Brain cancer and changes in immune system

Phase 4

Not yet recruiting

• Conditions: Glioblastoma multiforme

• Registration Number: 2024-512136-30-00
• Lead Sponsor: Orszagos Onkologiai Intezet

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-06-28
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 175

Inclusion Criteria

 Not recurrent glioblastoma multiforme patients (either after opus or with no opus) before radiotherapy and temozolomide therapy.  Recurrent patients who have already undergone other therapeutic intervention (surgery, radiotherapy and temozolomide therapy) and due to the recurrence of the disease, based on clinical experience, it is justified to start bevacizumab therapy.  Known relapse patients who are already receiving bevacizumab therapy.

Exclusion Criteria

 Unwillingness to sign the written Informed Consent Form.  History of psychiatric diseases and treatment.  Hypersensitivity to the active substance or to any of the excipients.  Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.  Participation in another clinical trial within 3 months prior to this study.  Known drug or chronic alcohol abuse, drug addiction.  Malignant disease other than GBM.  Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study.  Evidence of an uncooperative attitude.  Vulnerable subject.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.		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 Outcome Measures

Name	Time	Method
Investigation of plasma-derived extracellular vesicles (EV), their micro-RNA and protein content, and free DNA-RNA fragments. We do not perform genome sequencing.		Investigation of plasma-derived extracellular vesicles (EV), their micro-RNA and protein content, and free DNA-RNA fragments. We do not perform genome sequencing.

Trial Locations

Locations (2)

Orszagos Onkologiai Intezet; 🇭🇺 Budapest XII, Hungary

University Of Szeged; 🇭🇺 Szeged, Hungary

Orszagos Onkologiai Intezet

🇭🇺Budapest XII, Hungary

Zsolt Juranyi

Site contact

3612248779

juranyi.zsolt@oncol.hu