Treatment of newly diagnosed glioblastoma using targeted drug infusion

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 use of super-selective intra-arterial infusion of Cetuximab, a drug that targets the epidermal growth factor receptor (EGFR), for patients with newly diagnosed glioblastoma multiforme. The approach involves disrupting the blood-brain barrier to enhance drug delivery directly to the tumor site. The study aims to evaluate the safety and efficacy of this method in improving treatment outcomes for patients with this aggressive form of brain cancer. Participants will be closely monitored for their response to the treatment and any potential side effects.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: John Boockvar, MD
• Email: jboockvar@northwell.edu
• Phone: 212-434-4836

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Targeting brain tumors with a specific drug infusion and re-irradiation

  This study is testing a new way to deliver a drug directly to brain tumors in patients with certain aggressive types of glioblastoma to see if it can improve treatment results.

  Recruiting Phase 2 Northwell Health · New York, New York · NCT02800486

• Gene therapy combined with radiotherapy for brain tumors

  This study is testing a new gene therapy combined with targeted radiation to see if it can safely help people with recurrent high-grade brain tumors.

  Recruiting Phase 1 Henry Ford Health System · Detroit, Michigan · NCT05686798

• Combining TIL Therapy and Pembrolizumab for Advanced Brain Cancer

  This study is testing a new treatment that combines a type of immune therapy using patients' own tumor cells with Pembrolizumab to see if it helps people with advanced brain cancer feel better and live longer.

  Recruiting Phase 1/2 Essen Biotech · Beijing, Beijing Municipality · NCT06640582

• Using omental tissue to treat recurrent glioblastoma

  This study is testing whether using a piece of fat from the abdomen can help improve treatment for patients with recurrent glioblastoma by delivering medication and immune cells more effectively to the tumor site.

  Recruiting Northwell Health · New York, New York · NCT05979064

• Surgical technique to improve outcomes in glioblastoma patients

  This study is testing a new surgical method using special tissue flaps to see if it can help people with newly diagnosed glioblastoma live longer and have fewer problems after surgery.

  Recruiting Northwell Health · New York, New York · NCT05954858

• Infusion of Bevacizumab with Chemotherapy and Radiation for Newly Diagnosed Glioblastoma

  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.

  Recruiting Phase 3 Northwell Health · New York, New York · NCT05271240

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.