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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllNorthwell Health
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In plain words

What the trial is, and whether it could suit you

Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. GBM often has a high expression EFGR (Epidermal Growth Factor Receptor) which is blocked by Cetuximab (CTX). The investigators have recently completed a separate Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in revisio

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male or female patients of โ‰ฅ18 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.โˆ— \*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 โ‰ฅ70% (or the equivalent ECOG level of 0-2) and an expected survival of โ‰ฅ 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 WBCโ‰ฅ3000/mm3, absolute neutrophils โ‰ฅ1500/mm3 and platelets โ‰ฅ100,000/ mm3. Patients who are on Coumadin must have a platelet count of โ‰ฅ150,000/ 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 โ‰ค1.5X 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
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What it tests

  • Intra-arterial Cetuximab
  • Intra-arterial Mannitol
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Where

1 site
Lenox Hill Brain Tumor Center
New York, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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