drugset / Trial / NCT01468896

Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery

NCT01468896

Phase 1/2 Active not recruiting 23 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2011-10-26
Primary completion
2015-09-29
Completion
2027-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody Intravenous
Subject interleukin-12 Protein / enzyme biologic Subcutaneous