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Monoclonal Antibodies

Intra-arterial Cetuximab for Newly Diagnosed Glioblastoma

Phase 1 & 2

Recruiting

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with pathology confirmed histologic EGFR overexpression

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)

Must not have

Women who are pregnant or lactating

Patients who initiated or completed chemo/RT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is a study to see if a new treatment for brain cancer is safe and effective. The new treatment is a combination of standard chemotherapy and radiation therapy, with an additional drug given through a direct infusion into the brain.

Who is the study for?

This trial is for adults over 18 with newly diagnosed glioblastoma multiforme (GBM) showing high levels of EGFR. Participants must have good organ function, no recent chemo or radiation, and a life expectancy of at least three months. They should be able to perform daily activities well (Karnofsky score ≥70%) and not be pregnant or breastfeeding. Contraception use during the study and for three months after is required.

What is being tested?

The trial tests repeated intra-arterial infusions of Cetuximab combined with standard chemoradiation on patients with GBM after disrupting the blood-brain barrier. It's an open-label Phase I/II trial where patients receive three doses post-surgery alongside their regular treatment protocol.

What are the potential side effects?

Previous trials suggest that intra-arterial Cetuximab is generally well-tolerated with few adverse effects reported. However, potential side effects may include allergic reactions, issues related to infusion, and typical chemotherapy-associated risks like fatigue or lowered blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer shows high levels of EGFR.

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My blood counts meet the required levels for treatment.

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I have been newly diagnosed with glioblastoma multiforme.

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I have at least one tumor that can be measured and has been confirmed by a biopsy.

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I haven't had chemotherapy in the last 2 weeks or radiation in the last 8 weeks.

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I can care for myself and am expected to live for at least three more months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or breastfeeding.

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I have started or finished chemotherapy or radiation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Progression Free Survival (PFS)

Secondary study objectives

Heart rate

Toxicities graded according to the NCI Common Toxicity Criteria (CTCAE) version 4.03

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intra-arterial Cetuximab after BBBDExperimental Treatment2 Interventions

Mannitol 20% 12.5ml over two minutes for Blood Brain Barrier (BBB) disruption followed by CTX administered intra-arterially for three doses at a dose of 250mg/m2

0 / 8Eligibility criteria met