Intra-arterial Cetuximab for Newly Diagnosed Glioblastoma
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop chemotherapy for two weeks and external beam radiation for eight weeks before starting the treatment. Other medications are not specified, so it's best to discuss with the trial team.
What data supports the effectiveness of the drug Cetuximab for newly diagnosed glioblastoma?
A study showed that using Cetuximab with a method to open the blood-brain barrier, combined with standard cancer treatments, helped stabilize a brain tumor in a patient for at least 6 months without signs of it coming back. Another study found that Cetuximab, when used with a special type of radiation therapy, improved survival in rats with brain tumors.12345
What is the safety profile of cetuximab in humans?
Cetuximab is generally considered safe for use in humans, with the most common side effects being infusion reactions, acne-like skin rash, and nail disorders. Infusion reactions can be serious, so preventive treatment and careful monitoring are recommended. The skin rash and nail issues are usually mild and manageable with antibiotics.23567
How is the drug cetuximab used in treating newly diagnosed glioblastoma different from other treatments?
Cetuximab is unique in treating newly diagnosed glioblastoma because it is delivered directly into the brain's arteries after temporarily opening the blood-brain barrier, allowing the drug to reach the tumor more effectively. This method, combined with standard chemoradiation, may enhance treatment effectiveness for tumors with EGFR amplification.12358
What is the purpose of this trial?
Primary brain cancer kills up to 10,000 Americans a year. These 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 EFGR (Epidermal Growth Factor Receptor) which is blocked by Cetuximab (CTX). The investigators have recently completed a separate Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of CTX is well tolerated with few adverse effects. The investigators hypothesize that in patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and efficacious for our patients when combined with standard chemoradiation (STUPP protocol).This trial will be a non-randomized open label Phase I/II clinical trial. In addition to standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX intra-arterially after BBBD for a total of three doses at approximately post surgery days 30, 120 and 210.
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard chemoradiation (STUPP protocol) and intra-arterial Cetuximab after BBBD for three doses at approximately post-surgery days 30, 120, and 210
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
- Mannitol
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