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New treatment option for Glioblastoma
Official title Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
ClinicalTrials.gov ID: NCT02861898
What this study is testing
What is Intra-arterial Cetuximab?
Intra-arterial Cetuximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) and an expected survival of ≥ three months.
You likely can't join if
- 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...
- Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive...
- Patients with radiological evidence of leptomeningeal disease.
- Patients with history of allergic reaction to CTX
- Patients who initiated or completed chemo/RT
See the full eligibility 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...
- 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...
- Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.