Cetuximab + Interleukin-12 for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I/II trial studies the side effects and best dose of recombinant interleukin-12 when given together with cetuximab and to see how well they work in treating patients with squamous cell carcinoma of the head and neck that has come back, spread to another place in the body, or cannot be removed by surgery. Recombinant interleukin-12 may stimulate the white blood cells to kill tumor cells. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread Giving recombinant interleukin-12 together with cetuximab may kill more tumor cells.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or radiotherapy within 4 weeks before starting the trial.
What is the safety profile of Cetuximab and Interleukin-12 for head and neck cancer?
Cetuximab is generally considered safe, but it can cause infusion reactions, skin rashes, and nail disorders. Infusion reactions can be serious, so preventive measures are taken, and skin rashes are common but usually manageable. The safety profile of Cetuximab is favorable compared to traditional chemotherapy.12345
What makes the drug Cetuximab + Interleukin-12 unique for head and neck cancer?
What data supports the effectiveness of the drug Cetuximab combined with Interleukin-12 for head and neck cancer?
Cetuximab is effective in treating head and neck cancer by targeting cancer cells that overexpress a specific protein (EGFR) and activating immune cells to attack these cells. Combining Cetuximab with Interleukin-12 may enhance this immune response, potentially improving its effectiveness against cancer.127910
Who Is on the Research Team?
William E Carson
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with squamous cell carcinoma of the head and neck that's recurrent, metastatic, or inoperable. They must understand the study and consent to it, have a certain level of physical fitness (ECOG <=2), normal kidney function or specific creatinine clearance, no recent chemotherapy or radiotherapy, not be on other investigational drugs, and have no uncontrolled illnesses. Women who are pregnant or breastfeeding are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive cetuximab intravenously on day 1 and recombinant interleukin-12 subcutaneously on days 2 and 5, repeating every 2 weeks for 12 courses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cetuximab
- Recombinant Interleukin-12
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?
National Cancer Institute (NCI)
Lead Sponsor