Trial Summary
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.
Eligibility Criteria
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
My cancer in the head or neck area has returned or spread and cannot be removed by surgery.
You are expected to live for more than 6 months.
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times upper limit of normal
+9 more
Exclusion Criteria
You have had allergic reactions to drugs similar to IL-12 or other drugs used in this study.
I haven't had chemotherapy or radiotherapy in the last 4 weeks, or I've recovered from its side effects.
My brain cancer has been stable for 3 months without needing steroids.
+3 more
Participant Groups
The trial is testing how well recombinant interleukin-12 works with cetuximab in treating this type of cancer. It looks at side effects and best doses. Interleukin-12 may boost white blood cells to fight cancer while cetuximab could help the immune system attack cancer cells more effectively.
1Treatment groups
Experimental Treatment
Group I: Treatment (cetuximab and recombinant interleukin-12)Experimental Treatment3 Interventions
Patients receive cetuximab IV over 1-2 hours on day 1 and recombinant interleukin-12 SC on days 2 and 5 beginning in course 2. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving clinical response or stable disease may continue with therapy until disease progression.
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
Research Locations NearbySelect from list below to view details:
MedStar Georgetown University HospitalWashington, United States
Ohio State University Comprehensive Cancer CenterColumbus, OH
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)Lead Sponsor