37 Participants Needed

Cetuximab + Reirradiation for Brain Cancer

TW
John Boockvar, MD profile photo
Overseen ByJohn Boockvar, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Northwell Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications for the trial?

The trial requires that you stop chemotherapy at least two weeks before starting the treatment and avoid external beam radiation for eight weeks prior. The protocol does not specify other medications, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Cetuximab in treating brain cancer?

Research suggests that Cetuximab, when combined with radiotherapy, may have synergistic effects, meaning they work better together, in treating cancers. Although this study was not specifically on brain cancer, it indicates potential benefits if Cetuximab can reach the brain effectively.12345

Is cetuximab generally safe for use in humans?

Cetuximab has been used in treating metastatic colorectal cancer and is generally considered safe, though it can cause side effects like skin rash, diarrhea, nausea, vomiting, and fatigue. Severe side effects are rare, but skin toxicity and other mild to moderate side effects have been observed.12367

What makes the treatment Cetuximab + Reirradiation unique for brain cancer?

Cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), which is involved in the growth of many cancers. This treatment is unique because it combines cetuximab with reirradiation, potentially enhancing the effects of radiotherapy by targeting EGFR, which may improve outcomes for brain cancer patients if cetuximab can effectively cross the blood-brain barrier.12358

What is the purpose of this trial?

Primary 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 of EFGR (Epidermal Growth Factor Receptor), which is associated with poor prognosis. Several methods of inhibiting this receptor have been tested, including monoclonal antibodies, vaccines, and tyrosine kinase inhibitors. The investigators hypothesize that in patients with recurring GBM, intracranial superselective intra-arterial infusion of Cetuximab (CTX), at a dose of 250mg/m2 in conjunction with hypofractionated radiation, will be safe and efficacious and prevent tumor progression in patients with recurrent, residual GBM.

Research Team

John Andrew Boockvar, MD | Northwell Health

John Boockvar, MD

Principal Investigator

Northwell Health

Eligibility Criteria

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.

Inclusion Criteria

I have a confirmed diagnosis of a specific type of brain tumor that has returned or is not responding to treatment.
I can care for myself and am expected to live for at least three more months.
I haven't had chemotherapy in the last 2 weeks or radiation in the last 8 weeks.
See 7 more

Exclusion Criteria

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 history of allergic reaction to CTX
I do not have any major health or mental conditions that would make treatment risky for me.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-arterial Cetuximab with hypofractionated re-irradiation for three doses

6 months
Multiple visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Regular follow-up visits

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

2 years

Treatment Details

Interventions

  • Cetuximab
  • Hypofractionated re-irradiation
Trial Overview 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.
Participant Groups
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

Cetuximab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Erbitux for:
  • Locally or regionally advanced squamous cell carcinoma of the head and neck
  • Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
  • K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
  • BRAF V600E mutation-positive metastatic colorectal cancer
🇪🇺
Approved in European Union as Erbitux for:
  • Squamous cell carcinoma of the head and neck
  • K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials
481
Recruited
470,000+

Findings from Research

The study demonstrated that radiolabeled cetuximab (131I-Erbi) is stable for up to 72 hours and shows significantly higher uptake in cancer cells with epidermal growth factor receptors, indicating its potential effectiveness in targeting brain metastases.
Combining radiotherapy with 131I-Erbi resulted in a greater inhibition of tumor cell proliferation compared to using cetuximab alone, suggesting a synergistic effect that could enhance treatment outcomes for patients with multiple brain metastases.
Radioactive EGFR antibody cetuximab in multimodal cancer treatment: stability and synergistic effects with radiotherapy.Rades, D., Wolff, C., Nadrowitz, R., et al.[2018]
Cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor, which plays a crucial role in the growth of various cancers.
It received accelerated approval from the US FDA in February 2004 for treating metastatic colorectal cancer based on positive tumor response rates observed in Phase II clinical trials.
Cetuximab.Goldberg, RM.[2020]
In a post-marketing surveillance study involving 2126 patients with metastatic colorectal cancer, cetuximab was found to be well tolerated, with a median treatment duration of 15.3 weeks and a high incidence of adverse reactions at 89.6%.
The most common adverse reactions included skin disorders (83.7%) and infusion reactions (5.7%), primarily occurring during the first administration, indicating that while side effects are common, they align with previous reports and suggest that cetuximab is clinically useful in this patient population.
A Japanese post-marketing surveillance of cetuximab (Erbitux®) in patients with metastatic colorectal cancer.Ishiguro, M., Watanabe, T., Yamaguchi, K., et al.[2022]

References

Radioactive EGFR antibody cetuximab in multimodal cancer treatment: stability and synergistic effects with radiotherapy. [2018]
Cetuximab. [2020]
A Japanese post-marketing surveillance of cetuximab (Erbitux®) in patients with metastatic colorectal cancer. [2022]
[Topical application of EGF for the therapy of persisting corneal erosion under cetuximab treatment]. [2021]
Cetuximab: a guide to its use in combination with FOLFIRI in the first-line treatment of metastatic colorectal cancer in the USA. [2021]
Cetuximab and irinotecan as third line therapy in patients with advanced colorectal cancer after failure of irinotecan, oxaliplatin and 5-fluorouracil. [2018]
[The efficacy of cetuximab for metastatic colorectal cancer]. [2018]
Neutron capture therapy of epidermal growth factor (+) gliomas using boronated cetuximab (IMC-C225) as a delivery agent. [2018]
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