Infusion of Bevacizumab with Chemotherapy and Radiation for Newly Diagnosed Glioblastoma
A Phase III Randomized Trial of Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (Avastin) With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed Glioblastoma (GBM)
This study is testing if adding a special infusion of Bevacizumab to standard chemotherapy and radiation can help people with newly diagnosed glioblastoma live longer and feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 432 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | chemotherapy, radiation, Bevacizumab |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05271240 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of IDH-wild type GBM and a Karnofsky Performance Status of 70% or greater.
Not a fit: Patients with non-GBM brain tumors or those with a Karnofsky Performance Status below 70% may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival outcomes for patients with newly diagnosed GBM.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for improved outcomes in GBM treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.