CTIS2024-512136-30-00
Active, not recruiting
Phase 1
An open label, Phase IV study to assess immunological changes in patients with glioblastoma multiforme treated with bevacizumab infusion
Orszagos Onkologiai Intezet0 sites175 target enrollmentJune 20, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Orszagos Onkologiai Intezet
- Enrollment
- 175
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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