Treatment of newly diagnosed glioblastoma using targeted drug infusion
Phase I/II Trial of Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
This study is testing a new way to deliver a targeted drug directly to the brain tumor in people with newly diagnosed glioblastoma to see if it can improve their treatment outcomes.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | chemotherapy, radiation, Cetuximab |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT02861898 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of newly diagnosed glioblastoma and evidence of EGFR overexpression.
Not a fit: Patients who have received chemotherapy or radiation therapy shortly before the trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with glioblastoma.
How similar studies have performed: Previous studies using similar targeted infusion techniques have shown promise, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- 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
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.