Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM

Launched by NORTHWELL HEALTH · Mar 7, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat newly diagnosed glioblastoma (GBM), a type of aggressive brain cancer. Researchers want to see if a treatment called Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab, combined with chemotherapy and radiation, can help patients live longer and have better outcomes compared to the standard treatment of just chemotherapy and radiation. The trial is designed to gather important information about how effective this new treatment is and whether it can improve patients' quality of life.

To participate in this study, individuals must be 18 years or older and have a confirmed diagnosis of GBM. They should also be in relatively good health, with a certain level of ability to perform daily activities. Participants will undergo regular assessments and treatments, and they will be monitored closely for any side effects. This trial is currently recruiting participants, and it aims to provide valuable insights that could change how brain cancer treatments are delivered in the future.

Gender

ALL

Eligibility 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.