Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma

Launched by NORTHWELL HEALTH · Aug 5, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat newly diagnosed glioblastoma (GBM), a serious type of brain cancer. Researchers are testing a drug called Cetuximab (CTX), which targets a specific protein that is often overexpressed in GBM. The trial involves giving patients CTX directly into the arteries supplying their brain after a procedure that helps the drug cross the blood-brain barrier, making it more effective. Participants will receive a total of three doses of CTX along with the standard treatment of chemotherapy and radiation.

To be eligible for this trial, patients must be at least 18 years old and have a confirmed diagnosis of GBM with specific characteristics. They should not have received chemotherapy or radiation recently and must meet certain health criteria to ensure their safety during the study. If patients join the trial, they can expect to undergo the CTX treatment along with regular monitoring by the medical team to track their health and response to the therapy. This study aims to improve treatment options for GBM, which currently has a low survival rate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female patients of ≥18 years of age.
• • Patients with a documented histologic diagnosis of newly diagnosed glioblastoma multiforme (GBM)
• • Patients with pathology confirmed histologic EGFR overexpression
• • Patients must have at least one confirmed and evaluable tumor site.∗
• • \*A confirmed tumor site is one in which is biopsy-proven. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have been performed within two weeks of treatment on this research study.
• • Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) and an expected survival of ≥ three months.
• • No chemotherapy for two weeks prior to treatment under this research protocol and no external beam radiation for eight weeks prior to treatment under this research protocol.
• • Patients must have adequate hematologic reserve with WBC≥3000/mm3, absolute neutrophils ≥1500/mm3 and platelets ≥100,000/ mm3. Patients who are on Coumadin must have a platelet count of ≥150,000/ mm3
• • Pre-enrollment chemistry parameters must show: bilirubin\<1.5X the institutional upper limit of normal (IUNL); AST or ALT\<2.5X IUNL and creatinine\<1.5X IUNL.
• • Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL.
• • Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
• • Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.
• Exclusion Criteria:
• • Women who are pregnant or lactating.
• • Women of childbearing potential and fertile men will be informed as to the potential risk of conception while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
• • Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring
• • Patients with radiological evidence of leptomeningeal disease.
• • Patients with history of allergic reaction to CTX
• • Patients who initiated or completed chemo/RT