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Monoclonal Antibodies

Cetuximab + Reirradiation for Brain Cancer

Phase 2

Recruiting

Led By John Boockvar, MD

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 a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic oligoastrocytoma (AOA)

Patients must have a Karnofsky performance status ≥60% and an expected survival of ≥ three months

Must not have

Patients who have not failed standard Stupp protocol

Women who are pregnant or lactating

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 testing a new way to treat brain cancer that involves surgery, radiation, and chemotherapy. The goal is to see if this new method is safe and effective.

Who is the study for?

This trial is for adults over 18 with recurrent brain cancers like GBM, AA, or AOA that have high EGFR levels. They must be in good enough health to participate, not have had recent chemo or radiation therapy, and agree to use contraception. Pregnant women and those with severe medical conditions or allergies to Cetuximab are excluded.

What is being tested?

The study tests if a combination of intra-arterial Cetuximab (a monoclonal antibody) at a specific dose along with hypofractionated re-irradiation can safely treat recurring brain tumors by preventing tumor growth more effectively than current treatments.

What are the potential side effects?

Cetuximab may cause allergic reactions, skin rash, low magnesium levels, and other infusion-related reactions. Re-irradiation might lead to fatigue, hair loss at the treatment site, headaches, nausea and could potentially damage surrounding healthy brain tissue.

Eligibility Criteria

Inclusion Criteria

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

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I have a confirmed diagnosis of a specific type of brain tumor that has returned or is not responding to treatment.

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

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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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My cancer shows high levels of EGFR.

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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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My blood counts meet the required levels for treatment.

Exclusion Criteria

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

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I have not failed the standard Stupp protocol for my condition.

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I am not pregnant or breastfeeding.

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

Composite overall response rate (CORR) through the Response Evaluation Criteria In Solid Tumors (RECIST)

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 with Re-IrradiationExperimental Treatment3 Interventions

Mannitol 20% 12.5ml over two minutes for blood brain barrier (BBB) disruption followed by Cetuximab administered intra-arterially for three doses at a dose of 250 mg/m2 combined with hypofractionated re-irradiation

0 / 8Eligibility criteria met