Targeting brain tumors with a specific drug infusion and re-irradiation
Phase II Trial of Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory Glioblastoma Multiforme, Anaplastic Astrocytoma, and Anaplastic Oligoastrocytoma
PHASE2 · Northwell Health · NCT02800486
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.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health (other) |
| Drugs / interventions | chemotherapy, radiation, Cetuximab |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT02800486 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of super selective intra-arterial infusion of Cetuximab, combined with hypofractionated re-irradiation, for patients with relapsed or refractory glioblastoma, anaplastic astrocytoma, and anaplastic oligoastrocytoma. The approach aims to directly deliver the drug to the tumor site, potentially enhancing its efficacy while minimizing systemic exposure. The study focuses on patients with confirmed EGFR overexpression, a common characteristic in these aggressive brain tumors, to assess safety and effectiveness. By targeting the tumor more precisely, the trial seeks to improve treatment outcomes for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with relapsed or refractory glioblastoma, anaplastic astrocytoma, or anaplastic oligoastrocytoma who have confirmed EGFR overexpression.
Not a fit: Patients with non-recurrent brain tumors or those who have received chemotherapy or external beam radiation recently 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 aggressive brain tumors.
How similar studies have performed: While there have been various approaches to treating gliomas, this specific method of intra-arterial infusion combined with re-irradiation is relatively novel and has not been extensively tested in prior studies.
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 relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic oligoastrocytoma (AOA) * 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 * Patients must have a Karnofsky performance status ≥60% 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 of the potential unknown 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 completed chemo/RT less than 6 months prior to enrollment * Patients who have not failed standard Stupp protocol
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 — Northwell Health
- 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.
Conditions: Glioblastoma, Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Glioma, Brain Neoplasm, Brain Cancer, Brain Tumor, Brain Tumor, Recurrent