Infusion of Bevacizumab with Chemotherapy and Radiation for Newly Diagnosed Glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab combined with Temozolomide and radiation therapy in patients with newly diagnosed Glioblastoma Multiforme (GBM). Participants will receive an initial treatment of Mannitol to disrupt the blood-brain barrier, followed by Bevacizumab infusion and standard chemoradiation. The study aims to compare this combined approach to the standard treatment of Temozolomide and radiation alone, assessing improvements in progression-free and overall survival rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject is a male or female 18 years of age or older.
2. Subject has a confirmed diagnosis of GBM according to the 2021 WHO Classification of Tumors of the CNS. Accordingly, eligible GBM patients will comprise only IDH-wild type astrocytomas with microvascular proliferation or necrosis or one or more of 3 genetic parameters (TERT promoter mutations, EGFR gene amplification, or combined gain of entire chromosome 7 and loss of entire chromosome 10).
3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.
4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
5. Subject must be able to undergo MRI evaluation.
6. Subject meets the following laboratory criteria:

   i. White blood count ≥ 3,000/μL ii. Absolute neutrophil count ≥ 1,500/μL iii. Platelets ≥ 100,000/μL iv. Hemoglobin \> 10.0 g/dL (transfusion and/or ESA allowed) v. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN) vi. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x ULN vii. Blood urea nitrogen (BUN) and creatinine \< 1.5 x ULN
7. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.
8. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.
9. Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document (legally authorized representative permitted).

Exclusion Criteria:

1. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.
2. Subject has an IDH mutant astrocytoma or other non GBM brain tumor according to the 2021 WHO classification of Tumors of the CNS.
3. Subject intends to participate in another clinical trial
4. Subject has an active infection requiring treatment.
5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.
6. Subject has a history of other malignancy unless the patient has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment
7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.
8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
9. Subject, if female, is pregnant or is breast feeding.

Where it's running

• Lenox Hill Brain Tumor Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: John Boockvar, MD — Feinstein Institute for Medical Research/Lenox Hill Hospital
• Study coordinator: John Boockvar, MD
• Email: jboockvar@northwell.edu
• Phone: 212-434-3900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.