Cetuximab + Reirradiation for Brain Cancer
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?
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 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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intra-arterial Cetuximab with hypofractionated re-irradiation for three doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and progression-free survival
Treatment Details
Interventions
- Cetuximab
- Hypofractionated re-irradiation
Cetuximab is already approved in United States, European Union for the following indications:
- 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
- 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