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New treatment option for Glioblastoma
Official title Protective VEGF Inhibition for Isotoxic Dose Escalation in Glioblastoma
ClinicalTrials.gov ID: NCT05871021
What this study is testing
- What it's testing
- Glioblastoma is the most aggressive brain tumor and often recurs locally despite intensive treatment. Standard chemoradiotherapy with 60 Gy may not be sufficient to control the tumor, and dose escalation seems to be warranted, but causes more toxicity.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- IDH wild-type, MGMT unmethylated glioblastoma patients
- Informed consent
- Age ≥18 and ≤70 years, smoking or non-smoking, of any ethnic origin
- ECOG 0-2
- Neutrophil counts \>1500/µl, Platelet counts \>100.000/µl, Hemoglobin \> 8 g/dl, Serum creatinine \<1.5-fold upper limit of normal (ULN), Bilirubin...
You likely can't join if
- Evidence of significant hemorrhage on postoperative MRI of the brain. Patients with asymptomatic, minor hemosiderin deposition, resolving...
- people on any drug suspected to interfere with bevacizumab at the time of study inclusion
- Immuno-compromised patients, including known seropositivity for human immunodeficiency virus (HIV)
- Known hypersensitivity to any component of the investigational drugs or excipients (allergy to or other intolerability of bevacizumab or excipients)
- Any other significant medical illness or medically significant laboratory finding that would, in the investigator's judgement, make the patient...
- Incapability to undergo MRI
See the full eligibility criteria
- IDH wild-type, MGMT unmethylated glioblastoma patients
- Informed consent
- Age ≥18 and ≤70 years, smoking or non-smoking, of any ethnic origin
- ECOG 0-2
- Neutrophil counts \>1500/µl, Platelet counts \>100.000/µl, Hemoglobin \> 8 g/dl, Serum creatinine \<1.5-fold upper limit of normal (ULN), Bilirubin, AST or ALT \<2.5-fold ULN unless attributed to anticonvulsants...
- Adequate contraception
- Serum creatinine ≤ 1.5 x ULN AND patients with urine dipstick for proteinuria \< 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should show urine protein to creatinine ratio ≤ 1
- Evidence of significant hemorrhage on postoperative MRI of the brain. Patients with asymptomatic, minor hemosiderin deposition, resolving postsurgical hemorrhagic changes, or punctate intratumoral hemorrhage (e.g...
- people on any drug suspected to interfere with bevacizumab at the time of study inclusion
- Immuno-compromised patients, including known seropositivity for human immunodeficiency virus (HIV)
- Known hypersensitivity to any component of the investigational drugs or excipients (allergy to or other intolerability of bevacizumab or excipients)
- Any other significant medical illness or medically significant laboratory finding that would, in the investigator's judgement, make the patient inappropriate for this study, or would increase the risk associated with...
- Incapability to undergo MRI
- Prior treatment with bevacizumab for any indication
- Contraindication and/or hypersensitivity to bevacizumab or its excipients. For details check the Summary of Product Characteristics Aybintio®
- Significant cardiovascular disease defined as congestive heart failure (NYHA Class II, III, IV), unstable angina pectoris, or myocardial infarction within 6 months prior to enrolment
- Inadequately controlled hypertension (defined as a blood pressure of \> 150 mmHg systolic and/or \>100 mmHg diastolic on medication), or any prior history of hypertensive crisis or hypertensive encephalopathy
- History of clinically significant cerebrovascular events within 6 months prior to enrolment. This includes ischemic stroke or transient ischemic attack. Small, clinically silent perioperative ischemic changes are not...
- Significant vascular disease (e.g. aortic aneurysm, aortic dissection or recent peripheral arterial thrombosis) within 6 months prior to enrolment
- Evidence or history of recurrent thromboembolism (\> 1 episode of deep venous thrombosis / peripheral embolism) during the past 2 years
- Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
- Chronic daily intake of aspirin \> 325 mg/day or clopidogrel \> 75 mg /day
- History of intracranial abscess within 6 months prior to inclusion
- History of abdominal or tracheo-oesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrolment
- History of ≥ grade 2 hemoptysis according to NCI-CTC criteria within 1 month prior to inclusion
- Serious non-healing wound, ulcer or bone fracture
The study team makes the final eligibility decision.
Where it's taking place
- Augsburg, Germany
- Cologne, Germany
- Frankfurt, Germany
- Freiburg im Breisgau, Germany
- Leipzig, Germany
- Mannheim, Germany
- Munich, Germany
- Regensburg, Germany
- Tübingen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Augsburg, Germany; Cologne, Germany; Frankfurt, Germany; Freiburg im Breisgau, Germany; Leipzig, Germany; Mannheim, Germany and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.