Brain cancer and changes in immune system

Phase 1

• Conditions: Glioblastoma multiforme; Therapeutic area: Diseases [C] - Neoplasms [C04]; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2024-512136-30-00
• Lead Sponsor: Orszagos Onkologiai Intezet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-20
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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