Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA

Launched by NORTHWELL HEALTH · Jun 14, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with certain types of brain tumors, specifically recurrent glioblastoma, anaplastic astrocytoma, and anaplastic oligoastrocytoma. The researchers want to see if a targeted therapy called Cetuximab, combined with a specific type of radiation, can help prevent tumor growth and improve survival. Currently, brain cancer treatments are not very effective, and this trial aims to find a safer and more effective option for patients whose cancer has returned after initial treatment.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of one of the specified brain tumors that has not responded to previous treatments. They should have a measurable tumor site and meet certain health criteria, such as having a good level of daily functioning. Participants can expect to receive the new treatment along with careful monitoring by the medical team. It's important to note that women who are pregnant or breastfeeding cannot join the trial, and patients must agree to use contraception during and after the treatment period. This trial represents a potential new hope for patients battling these aggressive brain tumors.

Gender

ALL

Eligibility 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